OPTETRAK Comprehensive Knee System components recalled for inadequate packaging barrier
Exactech is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components due to inadequate oxygen barrier in vacuum bag packaging. No injuries have been reported.
What this means for you
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 hazard is a packaging deficiency—absence of an oxygen barrier in vacuum-sealed bags—affecting product integrity. This is a precautionary recall with theoretical, low-risk contamination concern.
Plain-English summary
Exactech, Inc. is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components and inserts that were distributed worldwide, including throughout the United States.
The recalled inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. This packaging deficiency was identified by the manufacturer.
The affected devices are in use or in inventory at healthcare facilities and in patients. As of this recall notification, no illnesses or injuries have been reported related to this packaging issue.
Patients and healthcare providers should contact Exactech for guidance on the affected units. Healthcare facilities should review their inventory and consult with the manufacturer regarding appropriate management of the recalled products.
The recalled product
- Product
- OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product L
- Manufacturer
- Exactech, Inc.
- Affected units
- 242,397
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. Item Number (Device Identifier
- Serial number(s)): 200-11-11 (10885862039934
- 1010599)
- 200-12-09 (10885862039965
- 0850770
- 0850771
- 0850773
- 0850776
- 0850778
- 1052587
- 1052589
- 1070149
- 1070150
- 1070151
- 1070152
- 1267585
- 1267586
- 1267588
- 1318739
- 1318740
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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