Exactech OPTETRAK Knee Implant Inserts Recalled for Inadequate Packaging
Exactech is recalling 8,985 OPTETRAK Comprehensive Knee System inserts due to insufficient oxygen barrier protection in vacuum packaging. The packaging deficiency was identified as the basis for the recall.
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 Class II recall of a medical device with a packaging defect affecting product integrity. The device is a risk-of-harm product (knee implant), and although no illnesses or injuries have been reported, potential device contamination poses serious clinical risks.
Plain-English summary
Exactech, Inc. is recalling the OPTETRAK Comprehensive Knee System, including OPTETRAK Logic RBK PS Tibial Components. The recall affects 8,985 devices.
The recalled inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. The company identified this packaging defect as the reason for the recall.
The affected products were distributed worldwide, including in the United States and numerous international markets. The recall expansion was announced on February 7, 2022.
Patients with these implants should contact their healthcare provider about the recall. Healthcare facilities should follow Exactech's instructions regarding any necessary actions for affected devices.
The recalled product
- Product
- OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
- Manufacturer
- Exactech, Inc.
- Affected units
- 8,985
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)): 02-012-38-1009 (10885862002358
- 2109242
- 2109243
- 2109244
- 2109245
- 2109246
- 2109247
- 2109248
- 2109249
- 2109250
- 2109251
- 2109252
- 2109253
- 2109254
- 2109255
- 2109256
- 2109257
- 2109258
- 2109261
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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