Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 7, 2024
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material p…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Howmedica Osteonics Corp. recalled DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728… - a moderate-severity action.
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728… was recalled by Howmedica Osteonics Corp. in February 7, 2024. Reason: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of o…. Check the official notice for the remedy. Verify recall #Z-0920-2024 with the FDA Devices before acting.
The recall
Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of o….
- Moderate
- severity level
- Class II
- classification
- February 7, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0920-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0920-2024) was formally reported on February 7, 2024, with the manufacturer initiating the action on December 1, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Howmedica Osteonics Corp. is listed as the recalling firm, operating out of Mahwah, NJ. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. Distribution data in the federal record shows the product reached: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreig…. 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
Unknown
Related Recalls
6
3 from same agency
Product description
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Reason for recall
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0920-2024 |
| Date reported | February 7, 2024 |
| Date initiated | December 1, 2023 |
| Recalling firm | Howmedica Osteonics Corp. |
| Firm location | Mahwah, NJ |
| Affected scope | Not disclosed |
| Distribution | Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added… |
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-0920-2024) 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? ▼
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611. Recalled by Howmedica Osteonics Corp..
Why was this product recalled? ▼
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0920-2024.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0920-2024) 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 February 7, 2024. 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.