Severity
Moderate
Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 00234700414 00234700416 00234700502 00234700504 00234700506 00234700508 00234700510 00234700512 00234700514 00234700602 00234700604 00234700606 00234700608 00234700610 00234700612 00234700614 00234700704 00234700706 00234700708 00234700710 00234700712 00234700714 00234700716 0023
Reported: November 13, 2019 Initiated: October 10, 2019 #Z-0307-2020 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-0307-2020) 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
Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 00234700414 00234700416 00234700502 00234700504 00234700506 00234700508 00234700510 00234700512 00234700514 00234700602 00234700604 00234700606 00234700608 00234700610 00234700612 00234700614 00234700704 00234700706 00234700708 00234700710 00234700712 00234700714 00234700716 00234700718 00234700720 00234700804 00234700806 00234700808 00234700810 00234700812 00234700814 00234700816 00234700818 00234700820 00234700904 00234700906 00234700908 00234700910 00234700912 00234700914 00234700916 00234700918 00234700920 00234701004 00234701006 00234701008 00234701010 00234701012 00234701014 00234701016 00234701018 00234701020 00234701104 00234701106 00234701108 00234701110 00234701204 00234701206 00234701208 00234701210 00234701304 00234701306 00234701308 00234701404 00234701406 00234701408 00234703500 00234703600
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-0307-2020 |
| 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? ▼
Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 00234700414 00234700416 00234700502 00234700504 00234700506 00234700508 00234700510 00234700512 00234700514 00234700602 00234700604 00234700606 00234700608 00234700610 00234700612 00234700614 00234700704 00234700706 00234700708 00234700710 00234700712 00234700714 00234700716 00234700718 00234700720 00234700804 00234700806 00234700808 00234700810 00234700812 00234700814 00234700816 00234700818 00234700820 00234700904 00234700906 00234700908 00234700910 00234700912 00234700914 00234700916 00234700918 00234700920 00234701004 00234701006 00234701008 00234701010 00234701012 00234701014 00234701016 00234701018 00234701020 00234701104 00234701106 00234701108 00234701110 00234701204 00234701206 00234701208 00234701210 00234701304 00234701306 00234701308 00234701404 00234701406 00234701408 00234703500 00234703600. 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-0307-2020.
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-0307-2020) 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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Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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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).