Orthopedic Knee Implants Lack Protective Oxygen Barrier in Packaging
Exactech OPTETRAK Comprehensive Knee System inserts were packaged in vacuum bags lacking an additional oxygen barrier layer, which could allow material degradation. The recall affects 2,774 devices 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 of a packaging defect without reported illnesses or injuries in the source material. The hazard is precautionary—missing oxygen barrier in vacuum bags—with no documented device failures.
Plain-English summary
The FDA has recalled the OPTETRAK Comprehensive Knee System, including all-polyethylene UNI Tibial Components manufactured by Exactech, Inc. This Class II recall affects 2,774 orthopedic knee implants.
The inserts were packaged in vacuum bags lacking an additional oxygen barrier layer. This packaging defect is the reason for the recall.
The affected devices were distributed worldwide, including throughout the United States and to more than 40 countries. Patients who received these implants should contact their surgeon or healthcare provider if they have any concerns about their device.
The recalled product
- Product
- OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
- Manufacturer
- Exactech, Inc.
- Affected units
- 2,774
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)): 252-12-01 (10885862065759
- 0757895
- 0757903
- 0757904
- 0757912
- 0779752
- 0779753
- 0779755
- 0779756
- 0779757
- 0779761
- 0779762
- 0779763
- 0779764
- 0779765
- 0779766
- 0779768
- 0779769
- 0779771
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
Same manufacturer · Exactech, Inc.
See all →- HighExactech Ergo modular impactor handle may be missing its cross-pin
FDA (Devices) · 2026-03-18
- HighExactech Equinoxe core instrument kits may have handles missing cross-pins
FDA (Devices) · 2026-03-18
- ModeratePilot tip converters recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamers recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamer 46mm recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
Same hazard · packaging defect
See all →- High
- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
Similar recalls
- HighExactech Optetrak Knee Implant System Recalled for Vacuum Seal Failure
FDA (Devices) · 2023-12-27
- HighOPTETRAK Inset Patella knee implants recalled for improper vacuum packaging
FDA (Devices) · 2024-06-26
- HighExactech Optetrak Logic Knee System Recalled for Vacuum Bag Failure
FDA (Devices) · 2023-12-27
- HighExactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging
FDA (Devices) · 2024-06-26
- ModerateOPTETRAK One Peg Patella components recalled for out-of-specification vacuum bags
FDA (Devices) · 2024-06-26
- HighExactech Optetrak Logic PS Knee System Vacuum Loss Recall
FDA (Devices) · 2023-12-27