Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 13, 2019
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
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Biomet, Inc. recalled Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 005850… - a moderate-severity action.
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 005850… 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-0323-2020 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-0323-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 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
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.
Affected scope
5,459,583 total devices
Related Recalls
6
3 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).
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. |
| 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-0323-2020) 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? ▼
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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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.