DONJOY REF:11-0447-9-ULTRASLING PRO — Class II medical device recall Z-1511-2021
Terminated recall by DJ Orthopedics de Mexico S.A. de C.V., reported 2021-05-05, distributed nationwide. failed rivet at the chafe tab of arm sling.
| Recall number | Z-1511-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DJ Orthopedics de Mexico S.A. de C.V., Tijuana, N/A, Mexico |
| Recall initiated | 2021-04-12 |
| Classified | 2021-04-29 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2024-03-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, FR, GB, JP, PL |
| UPC / GTIN / UDI-DI | 00190446673552 |
| Model numbers | 11-0447-9-ULTRASLINGPRO |
Product
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
Reason for recall
failed rivet at the chafe tab of arm sling.
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-1511-2021. 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.