Recall Z-2158-2024— Exactech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Exactech, Inc., initiated 2024-04-18. It names 3 FDA 510(k) clearances: K160484, K932690, K933610. Product: OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM. Reason: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-18
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
3 on FDA's record- K160484 — Optetrak Advanced Patella
- K932690 — EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
- K933610 — EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
Reason for recall
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Data sourced from openFDA. This site is unofficial and independent of the FDA.