OPTETRAK Comprehensive Knee System Custom Inserts Recalled for Packaging Defect
Exactech, Inc. is recalling 41 custom OPTETRAK knee implant inserts due to packaging defects. The inserts were packaged in vacuum bags lacking adequate oxygen barrier protection.
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: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is a packaging defect on orthopedic implants, which represents a voluntary precautionary recall. Per the rubric, precautionary recalls without reported harm typically score as Moderate (2).
Plain-English summary
Exactech, Inc. is recalling 41 custom OPTETRAK Comprehensive Knee System inserts. The Angled PS Inserts, CC Tibial Inserts, and CC Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
The affected devices have been distributed worldwide to healthcare facilities, including throughout the United States and internationally. The recall expansion was announced in February 2022. Healthcare providers and medical facilities should identify recalled devices using the device identifiers and serial numbers provided by the manufacturer.
The recalled product
- Product
- OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line…
- Manufacturer
- Exactech, Inc.
- Affected units
- 41
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)): 900-06-18 (10885862100375
- 1667962
- 1667963)
- 900-06-20 (10885862100382
- 1667796
- 1667797)
- 900-06-22(10885862100399
- 1667744
- 1667745)
- 900-08-18 (10885862100405
- 1667794
- 1667795)
- 900-08-20 (10885862100412
- 1667929
- 1667930)
- 900-08-22 (10885862100429
- 1667879
- 1667880)
- b. Item Number (Device Identifier
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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