Exactech Knee Patella Components Recalled Due to Out-of-Specification Vacuum Bags
Exactech is recalling OPTETRAK Three Peg Patella knee components packaged in out-of-specification vacuum bags. The affected products were 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 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 involving sterile orthopedic implants packaged in out-of-specification containers. No injuries or deaths reported, but improper packaging of high-risk medical devices presents a risk-of-harm to patients, warranting High severity classification.
Plain-English summary
Exactech, Inc. is recalling all affected OPTETRAK Three Peg Patella components in sizes 26MM, 29MM, 32MM, 35MM, 38MM, and 41MM. These ultra-high molecular weight polyethylene knee patella components were packaged in vacuum bags that do not meet manufacturing specifications.
The affected components were distributed worldwide. Specific lot numbers for each size have been identified by Exactech, Inc.
Healthcare facilities and patients who may have received affected components should contact Exactech, Inc. for additional information and guidance regarding their devices.
The recalled product
- Product
- OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
- Manufacturer
- Exactech, Inc.
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) 200-02-26
- UDI/DI 10885862039576
- Lot Numbers: 5881807
- 5908515
- 5968530
- 6007309
- 6038708
- 6038717
- 6066779
- 6345487
- 6345502
- 6358520
- 6431224
- 6431231
- 6551547
- 6557360
- 6723682
- 6734364
- 6771158
- 6865729
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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