Severity
Moderate
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 0
Reported: November 13, 2019 Initiated: October 10, 2019 #Z-0323-2020 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-0323-2020) 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
Units Affected
5,459,583 total devices
Related Recalls
6
6 from same agency
Product Description
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 00585205009 00585205010 00585205011 00585205012 00585205013 00585205014 00585205015 00585205016 00585205017 00585205018 00585205019 00585205209 00585205210 00585205211 00585205212 00585205213 00585205214 00585205215 00585205216 00585205217 00585205218 00585205219 00585205412 00585205413 00585205414 00585205415 00585205416 00585205417 00585205418 00585205419 00585207009 00585207010 00585207011 00585207012 00585207013 00585207014 00585207015 00585207016 00585207017 00585207018 00585207019 00585207409 00585207410 00585207411 00585207412 00585207413 00585207414 00585207415 00585207416 00585207417 00585207418 00585207419 500000001 500000005 500000010 500010000 502000001 502006006 502006011
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
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0323-2020 |
| 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.
Frequently Asked Questions
What product was recalled? ▼
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 00585205009 00585205010 00585205011 00585205012 00585205013 00585205014 00585205015 00585205016 00585205017 00585205018 00585205019 00585205209 00585205210 00585205211 00585205212 00585205213 00585205214 00585205215 00585205216 00585205217 00585205218 00585205219 00585205412 00585205413 00585205414 00585205415 00585205416 00585205417 00585205418 00585205419 00585207009 00585207010 00585207011 00585207012 00585207013 00585207014 00585207015 00585207016 00585207017 00585207018 00585207019 00585207409 00585207410 00585207411 00585207412 00585207413 00585207414 00585207415 00585207416 00585207417 00585207418 00585207419 500000001 500000005 500000010 500010000 502000001 502006006 502006011. 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-0323-2020.
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-0323-2020) 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
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
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).