FDA Device recall Z-2157-2024
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM
- FDA Device
- Class II
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class II recall of OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM by Exactech, citing exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2157-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-18 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Exactech |
| Distribution | n/a |
Product
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Reason
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Identifiers
| code_info | a) 200-05-23, UDI/DI 10885862039835, Lot Numbers: b) 200-05-26, UDI/DI 10885862039842, Lot Numbers: c) 200-05-29, UDI/DI 10885862039859, Lot Numbers: |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Exactech
- Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Des…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2157-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.