Severity
Moderate
FDA Devices recall · Reported November 13, 2019
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Zimmer Biomet, Inc. recalled Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 002347003… - a moderate-severity action.
Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 002347003… was recalled by Zimmer Biomet, Inc. in November 13, 2019. Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).. Check the official notice for the remedy. Verify recall #Z-0307-2020 with the FDA Devices before acting.
The recall
Zimmer Biomet, Inc. issued this moderate-severity FDA Devices recall-Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration)..
Sourced from official FDA Devices enforcement records. Verify recall #Z-0307-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 5,459,583 total devices.
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
5,459,583 total devices
Related Recalls
6
3 from same agency
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
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
| 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. |
| Firm location | Warsaw, IN |
| Affected scope | 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 13, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.