FDA Device recall Z-1238-2024
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial…
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial… by Synthes Usa Products, citing products not sterilized, sterility cannot be confirmed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1238-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-24 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
Reason
Products not sterilized, sterility cannot be confirmed
Identifiers
| code_info | UDI: 10887587057262 Lot Number: 499P371 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1238-2024%22
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