OPTETRAK Inset Patella knee implants recalled for improper vacuum packaging
Exactech is recalling OPTETRAK Inset Patella knee implants packaged in out-of-specification vacuum bags that may compromise product integrity during storage or sterilization.
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 of a medical implant with a potential risk of harm due to improper packaging that may compromise sterility or product integrity. No illnesses or injuries have been reported, placing this at the High severity level for risk-of-harm products without reported injury.
Plain-English summary
Exactech, Inc. is recalling all affected OPTETRAK Inset Patella knee implant components (Item Numbers 200-05-23 23MM, 200-05-26 26MM, and 200-05-29 29MM). These are ultra-high molecular weight polyethylene (UHMWPE) components used in knee replacement surgeries.
The recall was initiated because the components were packaged in vacuum bags that do not meet specification requirements. Out-of-specification packaging may compromise the sterility or integrity of the implant during storage or sterilization.
The affected products were distributed worldwide to hospitals, surgical centers, and other healthcare facilities. Patients who have received these implants should consult with their healthcare provider for guidance.
Further information will be available from Exactech and the FDA as the investigation continues.
The recalled product
- Product
- OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
- Manufacturer
- Exactech, Inc.
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 (7)
- a) 200-05-23
- UDI/DI 10885862039835
- Lot Numbers: b) 200-05-26
- UDI/DI 10885862039842
- Lot Numbers: c) 200-05-29
- UDI/DI 10885862039859
- Lot Numbers:
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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