Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 13, 2019
Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014 00224001016 00224001018 00224001020 00224001022 00224001024 00224001026 00224001028 00224001030 00224001032 00224001034 00224001036 00224001038 00224001040 00224001042 00224001046 00224001048 00224001114 002240
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 fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920… - a moderate-severity action.
Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920… 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-0328-2020 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-0328-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0328-2020) 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 fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014 00224001016 00224001018 00224001020 00224001022 00224001024 00224001026 00224001028 00224001030 00224001032 00224001034 00224001036 00224001038 00224001040 00224001042 00224001046 00224001048 00224001114 00224001116 00224001118 00224001120 00224001122 00224001124 00224001126 00224001128 00224001130 00224001132 00224001134 00224001136 00224001138 00224001140 00224001142 00224001144 00224001146 00224001214 00224001216 00224001218 00224001220 00224001222 00224001224 00224001226 00224001228 00224001230 00224001232 00224001234 00224001236 00224001238 00224001240 00224001242 00224001244 00224001246 00224001248 00224001314 00224001316 00224001318 00224001320 00224001322 00224001324 00224001326 00224001328 00224001330 00224001332 00224001334 00224001336 00224001338 00224001340 00224001342 00224001344 00224001346 00224001348 00224001414 00224001416 00224001418 00224001424 00224001426 00224001428 00224001430 00224001432 00224001434 00224001436 00224001438 00224001440 00224001442 00224001444 00224001446 00224001448 00225224008 00225224009 00225224010 00225224012 00225224013 00225226008 00225226009 00225226010 00225226011 00225226012 00225226013 00225228008 00225228009 00225228010 00225228011 00225228012 00225228013 00225228014 00225230008 00225230009 00225230010 00225230011 00225230012 00225230013 00225230014 00225230015 00225230016 00225232008 00225232009 00225232010 00225232011 00225232012 00225232013 00225232014 00225232015 00225232016 00225234008 00225234009 00225234010 00225234011 00225234012 00225234013 00225234014 00225234015 00225234016 00225236008 00225236009 00225236010 00225236011 00225236012 00225236013 00225236014 00225236015 00225236016 00225238008 00225238009 00225238010 00225238011 00225238012 00225238013 00225238014 00225240008 00225240009 00225240010 00225240011 00225240012 00225240013 00225240014 00225240015 00225242008 00225242009 00225242010 00225242011 00225242012 00225242013 00225242014 00225242015 00225242016 00225244008 00225244009 00225244010 00225244011 00225244012 00225244013 00225244014 00225244015 00225244016 00225246009 00225246010 00225246011 00225246012 00225246013 00225246014 00225246016 00225248010 00225248011 00225248012 00225248013 00225248014 00225248015 00225248016 00225250013 00225250014 00225250015 00225250016 00225318006 00225318008 00225318009 00225318011 00225320008 00225320009 00225320010 00225320011 00225320012 00225322006 00225322007 00225322008 00225322009 00225322010 00225322011 00225322012 00225322013 00225324006 00225324007 00225324008 00225324009 00225324010 00225324011 00225324012 00225324013 00225324014 00225326006 00225326007 00225326008 00225326009 00225326010 00225326011 00225326012 00225326013 00225326014 00225326015 00225328007 00225328008 00225328009 00225328010 00225328011 00225328012 00225328013 00225328014 00225328015 00225330006 00225330007 00225330008 00225330009 00225330010 00225330011 00225330012 00225330014 00225330015 00225332006 00225332007 00225332008 00225332009 00225332010 00225332011 00225332012 00225332013 00225332014 00225332015 00225334006 00225334007 00225334008 00225334009 00225334010 00225334011 00225334012 00225334013 00225334014 00225334015 00225336006 00225336007 00225336008 00225336009 00225336010 00225336011 00225336012 00225336013 00225336014 00225336015 00225338006 00225338007 00225338008 00225338009 00225338010 00225338011 00225338012 00225338013 00225338014 00225338015 00225340007 00225340008 002253400
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-0328-2020 |
| 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-0328-2020) 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 fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014 00224001016 00224001018 00224001020 00224001022 00224001024 00224001026 00224001028 00224001030 00224001032 00224001034 00224001036 00224001038 00224001040 00224001042 00224001046 00224001048 00224001114 00224001116 00224001118 00224001120 00224001122 00224001124 00224001126 00224001128 00224001130 00224001132 00224001134 00224001136 00224001138 00224001140 00224001142 00224001144 00224001146 00224001214 00224001216 00224001218 00224001220 00224001222 00224001224 00224001226 00224001228 00224001230 00224001232 00224001234 00224001236 00224001238 00224001240 00224001242 00224001244 00224001246 00224001248 00224001314 00224001316 00224001318 00224001320 00224001322 00224001324 00224001326 00224001328 00224001330 00224001332 00224001334 00224001336 00224001338 00224001340 00224001342 00224001344 00224001346 00224001348 00224001414 00224001416 00224001418 00224001424 00224001426 00224001428 00224001430 00224001432 00224001434 00224001436 00224001438 00224001440 00224001442 00224001444 00224001446 00224001448 00225224008 00225224009 00225224010 00225224012 00225224013 00225226008 00225226009 00225226010 00225226011 00225226012 00225226013 00225228008 00225228009 00225228010 00225228011 00225228012 00225228013 00225228014 00225230008 00225230009 00225230010 00225230011 00225230012 00225230013 00225230014 00225230015 00225230016 00225232008 00225232009 00225232010 00225232011 00225232012 00225232013 00225232014 00225232015 00225232016 00225234008 00225234009 00225234010 00225234011 00225234012 00225234013 00225234014 00225234015 00225234016 00225236008 00225236009 00225236010 00225236011 00225236012 00225236013 00225236014 00225236015 00225236016 00225238008 00225238009 00225238010 00225238011 00225238012 00225238013 00225238014 00225240008 00225240009 00225240010 00225240011 00225240012 00225240013 00225240014 00225240015 00225242008 00225242009 00225242010 00225242011 00225242012 00225242013 00225242014 00225242015 00225242016 00225244008 00225244009 00225244010 00225244011 00225244012 00225244013 00225244014 00225244015 00225244016 00225246009 00225246010 00225246011 00225246012 00225246013 00225246014 00225246016 00225248010 00225248011 00225248012 00225248013 00225248014 00225248015 00225248016 00225250013 00225250014 00225250015 00225250016 00225318006 00225318008 00225318009 00225318011 00225320008 00225320009 00225320010 00225320011 00225320012 00225322006 00225322007 00225322008 00225322009 00225322010 00225322011 00225322012 00225322013 00225324006 00225324007 00225324008 00225324009 00225324010 00225324011 00225324012 00225324013 00225324014 00225326006 00225326007 00225326008 00225326009 00225326010 00225326011 00225326012 00225326013 00225326014 00225326015 00225328007 00225328008 00225328009 00225328010 00225328011 00225328012 00225328013 00225328014 00225328015 00225330006 00225330007 00225330008 00225330009 00225330010 00225330011 00225330012 00225330014 00225330015 00225332006 00225332007 00225332008 00225332009 00225332010 00225332011 00225332012 00225332013 00225332014 00225332015 00225334006 00225334007 00225334008 00225334009 00225334010 00225334011 00225334012 00225334013 00225334014 00225334015 00225336006 00225336007 00225336008 00225336009 00225336010 00225336011 00225336012 00225336013 00225336014 00225336015 00225338006 00225338007 00225338008 00225338009 00225338010 00225338011 00225338012 00225338013 00225338014 00225338015 00225340007 00225340008 002253400. 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-0328-2020.
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-0328-2020) 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.