Knee replacement system inserts recalled for missing oxygen barrier in packaging
Exactech is recalling knee implant system inserts that were packaged in vacuum bags lacking an oxygen barrier layer. This packaging defect may compromise product sterility and integrity.
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: FDA classified this recall as Class II. Although no injuries or illnesses have been reported, the packaging defect on surgical knee implants—where inserts lack an oxygen barrier layer—poses a potential risk to product sterility and structural integrity. This qualifies as a risk-of-harm product without yet-reported injuries per the rubric.
Plain-English summary
Exactech, Inc. is recalling the OPTETRAK Comprehensive Knee System, including OPTETRAK RBK PS Tibial Components, affecting 33,103 devices. The recalled inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer necessary for proper preservation.
Without the oxygen barrier, oxygen may reach and potentially degrade the inserts during storage and distribution. This packaging defect could compromise the sterility or structural integrity of the components, posing a risk to patient safety.
The affected devices were distributed worldwide, including to healthcare facilities throughout the United States and in over 40 countries. Hospitals and surgical centers that received these components may have affected inventory.
Healthcare facilities should not use the recalled inserts. Patients who have received these implants should contact their healthcare provider or surgeon with questions. Specific device identifiers and serial numbers of affected products are available in the FDA recall notice.
The recalled product
- Product
- OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
- Manufacturer
- Exactech, Inc.
- Affected units
- 33,103
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)
- Item Number (Device Identifier
- Serial number(s)): 264-21-09 (10885862068842
- 0754387
- 0754388
- 0754390
- 0754391
- 0754392
- 0754393
- 0754394
- 0754396
- 0754397
- 0754398
- 0754399
- 0754400
- 0754401
- 0754402
- 0754403
- 0754404
- 0754405
- 0754406
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.
See all 9 products in this recall →Related recalls
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