OPTETRAK One Peg Patella components recalled for out-of-specification vacuum bags
Exactech is recalling OPTETRAK One Peg Patella knee implants due to vacuum bags packaged below specification. The recall affects units with multiple lot numbers distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The packaging defect is a precautionary concern without documented adverse events, meeting the criteria for Moderate severity.
Plain-English summary
Exactech, Inc. is recalling OPTETRAK One Peg Patella knee implants because the ultra-high molecular weight polyethylene (UHMWPE) components were packaged in out-of-specification vacuum bags. This packaging defect affects all units manufactured with the identified lot numbers.
The recall encompasses six product sizes, ranging from 26mm to 41mm, and has worldwide distribution. Healthcare providers and facilities should verify their implant inventories against the affected lot numbers provided in this recall.
Patients who have received these implants should consult with their healthcare provider or contact Exactech for guidance regarding the packaging defect.
The recalled product
- Product
- OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
- Manufacturer
- Exactech, Inc.
- Hazard
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 (20)
- a) 200-03-26
- UDI/DI 10885862039637
- Lot Numbers: 6389536
- 6389549
- 6389551
- 6389538
- 6389540
- 6389531
- 6389537
- 6389529
- 6389534
- 6389542
- 6389545
- 6711546
- 6711550
- 6389547
- 6389548
- 6389555
- 6711540
- b) 200-03-29
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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