FDA Device recall Z-0581-2025
BIORAPTOR Suture Anchors
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of BIORAPTOR Suture Anchors by Smith And Nephew, citing sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0581-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-29 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Reason
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Identifiers
| code_info | Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469…Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692. |
|---|
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 Smith And Nephew
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
FDA Device · Class II · 2026-06-24 · Smith And Nephew - BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener
FDA Device · Class II · 2025-12-24 · Smith And Nephew - META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
FDA Device · Class II · 2025-05-28 · Smith And Nephew - Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar co…
FDA Device · Class II · 2024-11-13 · Smith And Nephew - smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163
FDA Device · Class II · 2024-11-06 · Smith And Nephew
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0581-2025%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.