Radial Head Replacement System Implant is a one-piece — Class II medical device recall Z-1072-2022
Ongoing recall by Synthes (USA) Products LLC, reported 2022-05-18, distributed nationwide. DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU
| Recall number | Z-1072-2022 |
|---|---|
| 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 | 2022-04-07 |
| Classified | 2022-05-12 |
| Reported by FDA | 2022-05-18 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 10886982300522, 10886982300539, 10886982300546, 10886982300553, 10886982300560, 10886982300577, 10886982300584, 10886982300591, 10886982300607, 10886982300614, 10886982300621, 10886982300638, 10886982300645, 10886982300652, 10886982300669, 10886982300676, 10886982300683, 10886982300690, 10886982300706, 10886982300713, 10886982300720, 10886982300737, 10886982300744, 10886982300751, 10886982300768 and 6 more |
Product
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
Reason for recall
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
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-1072-2022. 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.