RAPIDSORB IPS Battery Pack — Class II medical device recall Z-1238-2024
Ongoing recall by Synthes (USA) Products LLC, reported 2024-03-13, distributed nationwide. Products not sterilized, sterility cannot be confirmed
| Recall number | Z-1238-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2024-01-24 |
| Classified | 2024-03-01 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CZ, DE, ES, FI, FR, GB, IE, KR, KW, MX, NL, SK, TW, ZA |
| Quantity | 10 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10887587057262 |
| Lot numbers | 499P371 |
| Model numbers | 530.553.01S |
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 for recall
Products not sterilized, sterility cannot be confirmed
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1238-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.