Exactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging
Exactech is recalling OPTETRAK Advanced Patella knee implant components packaged in vacuum bags that did not meet manufacturing specifications. Improper packaging could compromise product sterility.
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 3/5 (High).
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 Class II recall involves improper vacuum bag packaging for surgical knee implants. While no illnesses or injuries have been reported, vacuum integrity is critical for sterility in surgical implants. This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric's criterion for High severity.
Plain-English summary
Exactech, Inc., is recalling OPTETRAK Advanced Patella 3-peg knee implant components manufactured with out-of-specification vacuum bag packaging. These ultra-high molecular weight polyethylene (UHMWPE) implants are used in knee replacement surgery and are available in five sizes: 26mm, 29mm, 32mm, 35mm, and 38mm. The products have been distributed worldwide.
The vacuum bags used for packaging do not meet manufacturing specifications, which could compromise the sterility of these surgical implants. Proper vacuum sealing is essential to maintain the integrity and safety of implants intended for surgical implantation.
Multiple lot numbers have been identified across all five implant sizes. Healthcare facilities and patients with these implants should verify the lot number of their product against the recall notice.
The recalled product
- Product
- OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
- Manufacturer
- Exactech, Inc.
- Category
- Medical Device — Knee 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 (20)
- a) 200-07-26
- UDI/DI 10885862314260
- Lot Numbers: 5937497
- 6015804
- 6038627
- 6038629
- 6038631
- 6067823
- 6067835
- 6067836
- 6305296
- 6305298
- 6305299
- 6535789
- 6535803
- 6535805
- 6535809
- 6590076
- 6645243
- 6673338
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.
See all 4 products in this recall →Related recalls
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