PlainRecalls
FDA Devices Verify with FDA Devices → Moderate Class II Terminated

Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008000 00522400800 00522400900 00522406201 00541001401 00541001501 00541001502 00541001601 00541001602 00541001701 00541001702 00541001801 00541001802 00541201501 00541201502 00541201601 00541201602 0054120

Reported: November 13, 2019 Initiated: October 10, 2019 #Z-0321-2020 5,459,583 total devices units

Zimmer Biomet, Inc. issued this FDA Devices recall on November 13, 2019. Classified as Moderate severity (Class II). Approximately 5,459,583 total devices units are affected. The recall was issued because: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0321-2020) was formally reported on November 13, 2019, with the manufacturer initiating the action on October 10, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 5,459,583 total devices units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Distribution data in the federal record shows the product reached: Distributed nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

5,459,583 total devices

Related Recalls

6

6 from same agency

Product Description

Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008000 00522400800 00522400900 00522406201 00541001401 00541001501 00541001502 00541001601 00541001602 00541001701 00541001702 00541001801 00541001802 00541201501 00541201502 00541201601 00541201602 00541201701 00541201702 00541201801 00541201802 00541401301 00541401302 00541401401 00541401402 00541401501 00541401502 00541401601 00541401602 00541401701 00541401702 00541601401 00541601402 00541601501 00541601502 00541601601 00541601602 00575001301 00575001302 00575001305 00575001306 00575001401 00575001402 00575001405 00575001406 00575001501 00575001502 00575001505 00575001506 00575001601 00575001602 00575001605 00575001606 00575001701 00575001702 00575001705 00575001706 00575201301 00575201302 00575201305 00575201306 00575201401 00575201402 00575201405 00575201406 00575201501 00575201502 00575201505 00575201506 00575201601 00575201602 00575201605 00575201606 00575201701 00575201702 00575201705 00575201706 00576201351 00576201352 00576201451 00576201452 00576201551 00576201552 00576201651 00576201652 00576201751 00576201752 00576401351 00576401352 00576401451 00576401452 00576401551 00576401552 00576401651 00576401652 00576401751 00576401752 00579002000 00579002100 00579002200 00579002300 00579002400 00579002500 00579002600 00579002700 00579002800 00579002900 00579004511 00579004512 00579005511 00579005512 00579006511 00579006512 00579007511 00579007512 00584200101 00584200102 00584200201 00584200202 00584200301 00584200302 00584200401 00584200402 00584200501 00584200502 00584200601 00584200602 00584201101 00584201102 00584201201 00584201202 00584201301 00584201302 00584201401 00584201402 00584201501 00584201502 00584201601 00584201602 00584201701 00584201702 00588000110 00588000210 00588000310 00588000410 00588000510 00588000610 00591602000 00591602001 00591603000 00591603001 00591604000 00591604001 00591604017 00591605000 00591605001 00591605017 00591606000 00591606001 00591607000 00591607001 00591607020 00591608000 00591608001 00591800200 00591800300 00591800400 00591800500 00591800600 00591800700 00591800800 00592601101 00592601102 00592601201 00592601202 00592601301 00592601302 00592601401 00592601402 00592601501 00592601502 00595001201 00595001202 00595001301 00595001302 00595001305 00595001306 00595001401 00595001402 00595001405 00595001406 00595001501 00595001502 00595001505 00595001506 00595001601 00595001602 00595001605 00595001606 00595001701 00595001702 00595001705 00595001706 00595002701 00595002702 00595003701 00595003702 00595003712 00595004701 00595004702 00595005701 00595005702 00595006745 00595006775 00595009000 00595201201 00595201202 00595201301 00595201302 00595201305 00595201306 00595201401 00595201402 00595201405 00595201406 00595201501 00595201502 00595201505 00595201506 00595201601 00595201602 00595201605 00595201606 00595201701 00595201702 00595201705 00595201706 00595409000 00595601201 00595601202 00595601301 00595601302 00595601305 00595601306 00595601401 00595601402 00595601405 00595601406 00595601501 00595601502 00595601505 00595601506 00595601601 00595601602 00595601605 00595601606 00595601701 00595601702 00595601705 00595601706 00596001151 00596001152 00596001251 00596001252 00596001351 00596001352 00596001451 00596001452 00596001551 00596001552 00596001651 00596001652 00596001751 00596001752 00596001851 00596001852 00596003701 00596003702 00596003710 00596004701 00596004702 00596004710 00596005701 00596005710 00596009900 00596201251 0059620125

Reason for Recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
5,459,583 total devices
Distribution
Distributed nationwide.
Location
Warsaw, IN

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-0321-2020
Date reported November 13, 2019
Date initiated October 10, 2019
Recalling firm Zimmer Biomet, Inc.
Units affected 5,459,583 total devices
Distribution Distributed nationwide.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

5,459,583 total devices units affected — million-unit bracket.

Regional (<10K units) —
Multi-state (10K – 100K units) —
Large-scale (100K – 1M units) —
Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼
Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008000 00522400800 00522400900 00522406201 00541001401 00541001501 00541001502 00541001601 00541001602 00541001701 00541001702 00541001801 00541001802 00541201501 00541201502 00541201601 00541201602 00541201701 00541201702 00541201801 00541201802 00541401301 00541401302 00541401401 00541401402 00541401501 00541401502 00541401601 00541401602 00541401701 00541401702 00541601401 00541601402 00541601501 00541601502 00541601601 00541601602 00575001301 00575001302 00575001305 00575001306 00575001401 00575001402 00575001405 00575001406 00575001501 00575001502 00575001505 00575001506 00575001601 00575001602 00575001605 00575001606 00575001701 00575001702 00575001705 00575001706 00575201301 00575201302 00575201305 00575201306 00575201401 00575201402 00575201405 00575201406 00575201501 00575201502 00575201505 00575201506 00575201601 00575201602 00575201605 00575201606 00575201701 00575201702 00575201705 00575201706 00576201351 00576201352 00576201451 00576201452 00576201551 00576201552 00576201651 00576201652 00576201751 00576201752 00576401351 00576401352 00576401451 00576401452 00576401551 00576401552 00576401651 00576401652 00576401751 00576401752 00579002000 00579002100 00579002200 00579002300 00579002400 00579002500 00579002600 00579002700 00579002800 00579002900 00579004511 00579004512 00579005511 00579005512 00579006511 00579006512 00579007511 00579007512 00584200101 00584200102 00584200201 00584200202 00584200301 00584200302 00584200401 00584200402 00584200501 00584200502 00584200601 00584200602 00584201101 00584201102 00584201201 00584201202 00584201301 00584201302 00584201401 00584201402 00584201501 00584201502 00584201601 00584201602 00584201701 00584201702 00588000110 00588000210 00588000310 00588000410 00588000510 00588000610 00591602000 00591602001 00591603000 00591603001 00591604000 00591604001 00591604017 00591605000 00591605001 00591605017 00591606000 00591606001 00591607000 00591607001 00591607020 00591608000 00591608001 00591800200 00591800300 00591800400 00591800500 00591800600 00591800700 00591800800 00592601101 00592601102 00592601201 00592601202 00592601301 00592601302 00592601401 00592601402 00592601501 00592601502 00595001201 00595001202 00595001301 00595001302 00595001305 00595001306 00595001401 00595001402 00595001405 00595001406 00595001501 00595001502 00595001505 00595001506 00595001601 00595001602 00595001605 00595001606 00595001701 00595001702 00595001705 00595001706 00595002701 00595002702 00595003701 00595003702 00595003712 00595004701 00595004702 00595005701 00595005702 00595006745 00595006775 00595009000 00595201201 00595201202 00595201301 00595201302 00595201305 00595201306 00595201401 00595201402 00595201405 00595201406 00595201501 00595201502 00595201505 00595201506 00595201601 00595201602 00595201605 00595201606 00595201701 00595201702 00595201705 00595201706 00595409000 00595601201 00595601202 00595601301 00595601302 00595601305 00595601306 00595601401 00595601402 00595601405 00595601406 00595601501 00595601502 00595601505 00595601506 00595601601 00595601602 00595601605 00595601606 00595601701 00595601702 00595601705 00595601706 00596001151 00596001152 00596001251 00596001252 00596001351 00596001352 00596001451 00596001452 00596001551 00596001552 00596001651 00596001652 00596001751 00596001752 00596001851 00596001852 00596003701 00596003702 00596003710 00596004701 00596004702 00596004710 00596005701 00596005710 00596009900 00596201251 0059620125. Recalled by Zimmer Biomet, Inc.. Units affected: 5,459,583 total devices.
Why was this product recalled? ▼
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0321-2020.
Where was the recalled product distributed? ▼
Distribution: Distributed nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0321-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).