Conformis Identity Imprint PS Tibial Tray Size 4 Packaging Error
Conformis is recalling Identity Imprint PS Tibial Tray Size 4 implants due to a packaging error where Size 5 components were placed in Size 4 boxes with incorrect lot numbers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a packaging and labeling error for a surgical implant. While no injuries have been reported, a mislabeled wrong-size implant poses a risk of patient harm during surgery. This meets the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Conformis, Inc. is recalling Identity Imprint PS Tibial Tray Size 4, Lot 540287. During manufacturing, Size 5 Tibial Tray components from Lot 508287 were packaged into Size 4 boxes labeled with Lot 540287. The two lots were swapped between the pouching and final packing stages.
This packaging and labeling error creates a risk that orthopedic surgeons could implant the wrong-sized tibial component during knee replacement surgery. Using an incorrectly-sized implant could affect surgical fit and patient outcomes.
Three units of the affected devices were distributed nationwide in Florida, Kansas, and New Hampshire.
Healthcare providers and patients who have received these devices should verify the actual product size matches the box label before use. Hospitals and surgical centers should review their inventory and isolate any affected lots pending verification.
The recalled product
- Product
- Identity Imprint PS Tibial Tray Size 4: Lot 540287
- Manufacturer
- Conformis, Inc.
- Hazard
- packaging-error
- wrong-size-implant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog Number: TPS-301-T04S
- UDI#: M572TPS301T04S011
- Lot number 540287
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27