PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported November 13, 2019

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

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

Recall #
Z-0307-2020
Affected scope
5,459,583 total devices
Initiated
October 10, 2019
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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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)..

Moderate
severity level
Class II
classification
November 13, 2019
reported

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.

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 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.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

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

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).

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-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.

  • Check the recall number (Z-0307-2020) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

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.

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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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.