FDA Device recall Z-0573-2016
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERI…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERI… by Smith And Nephew, citing one lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning wi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0573-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-09 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | FL, IN, MO, TX |
Product
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.
Reason
One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.
Identifiers
| code_info | Batch # 15GM07831 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0573-2016%22
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