PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported November 13, 2019

Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353 32855090354 32855090368 32855090369 32855090375 32855090376 32855090395 32855090396 32855090402 32855090409 32855090414 32855090434 32855090437 32855090439

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

Recall #
Z-0302-2020
Affected scope
5,459,583 total devices
Initiated
October 10, 2019
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Zimmer Biomet, Inc. recalled Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 328… - a moderate-severity action.

Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 328… 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-0302-2020 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-0302-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353 32855090354 32855090368 32855090369 32855090375 32855090376 32855090395 32855090396 32855090402 32855090409 32855090414 32855090434 32855090437 32855090439 32855090448 32855090450 32855090465 32855090484 32855090496 32855090497 32855090498 32855090501 32855090507 32855090512 32855090519 32855090520 32855090531 32855090543 32855090576 32855090585 32855090586 32855090593 32855090598 32855090599 32855090609 32855090615 32855090622 32855090628 32855090636 32855090637 32855090638 32855090640 32855090658 32855090659 32855090661 32855090715 32855090734 32855510763 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510808 32855510822 32855510843 32855510844 32855140373 32855411710 32855430479 32855430480 32855430496 32855430498 32855430519 32855430529 32855430533 32855430535 32855430542 32855430544 32855430582 32855430588 32855450430 32855450439 32855450471 32855450483 32855450525 32855470651 32855470715 32855470793 32855470795 32855470796 32855470866 32855470920 32855470921 32855470923 32855480803 32855480808 32855480823 32855480824 32855480828 32855480829 32855480945 32855480963 32855480990 32855481016 32855910440 32855910454 32855910455 32855910456 32855910475 32855910485 32873400307

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-0302-2020
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-0302-2020) 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 Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353 32855090354 32855090368 32855090369 32855090375 32855090376 32855090395 32855090396 32855090402 32855090409 32855090414 32855090434 32855090437 32855090439 32855090448 32855090450 32855090465 32855090484 32855090496 32855090497 32855090498 32855090501 32855090507 32855090512 32855090519 32855090520 32855090531 32855090543 32855090576 32855090585 32855090586 32855090593 32855090598 32855090599 32855090609 32855090615 32855090622 32855090628 32855090636 32855090637 32855090638 32855090640 32855090658 32855090659 32855090661 32855090715 32855090734 32855510763 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510808 32855510822 32855510843 32855510844 32855140373 32855411710 32855430479 32855430480 32855430496 32855430498 32855430519 32855430529 32855430533 32855430535 32855430542 32855430544 32855430582 32855430588 32855450430 32855450439 32855450471 32855450483 32855450525 32855470651 32855470715 32855470793 32855470795 32855470796 32855470866 32855470920 32855470921 32855470923 32855480803 32855480808 32855480823 32855480824 32855480828 32855480829 32855480945 32855480963 32855480990 32855481016 32855910440 32855910454 32855910455 32855910456 32855910475 32855910485 32873400307. 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-0302-2020.
Where was the recalled product distributed? ▼
Distribution: Distributed nationwide..
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.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported November 13, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026