FDA Devices recall · Reported November 13, 2019
ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 00234701714 00234701716 00234701718 00234701802 00234701804 00234701806 00234701808 00234701810 00234701812 00234701814 00234701816 00234701818 47235701704 47235701706 47235701708 47235701710 47235701712 47
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Zimmer Biomet, Inc. recalled ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 0023470… - a moderate-severity action.
ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 0023470… 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-0305-2020 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-0305-2020 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
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
ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 00234701714 00234701716 00234701718 00234701802 00234701804 00234701806 00234701808 00234701810 00234701812 00234701814 00234701816 00234701818 47235701704 47235701706 47235701708 47235701710 47235701712 47235701714 47235701716 47235701804 47235701806 47235701808 47235701810 47235701812 47235701814 47235701816
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-0305-2020 |
| 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-0305-2020) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
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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Methodology · Corrections · Archive as of August 2026