CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
Identity Imprint PS Tibial Tray Size recalled by Conformis
Conformis is recalling Identity Imprint PS Tibial Tray Size 4, distributed nationwide in the US. The recall was initiated on 11 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1591-2024
- FDA event ID
- 94288
- Recalling firm
- Conformis, Billerica, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2024
- FDA classified
- 17 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 11 Mar 2024 | Recall initiated by company | |
| 17 Apr 2024 | Classified by FDA | +37 days |
| 24 Apr 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Where it was distributed
US Nationwide distribution in the states of FL, KS and NH.
Questions about this recall
Why was it recalled?
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Which lots are affected?
Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
Where was it sold?
US Nationwide distribution in the states of FL, KS and NH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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