ATTUNE Measured Sizing and Rotation Guide-to size the femur and align… — Class II medical device recall Z-1419-2022
Ongoing recall by DePuy Orthopaedics, Inc., reported 2022-07-27, distributed nationwide. Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has
| Recall number | Z-1419-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2022-06-29 |
| Classified | 2022-07-20 |
| Reported by FDA | 2022-07-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IT, JP, KR, KW, LT, MA, MX, NL, NO, NZ, PE, PL, PT, RO, RS, SA, SG, TH, TW, VN, ZA |
| Quantity | 872 units |
| UPC / GTIN / UDI-DI | 10603295434061 |
| Lot numbers | AB4536235, AB4733296, AB4810808, AB4841493, AB4841495, AB4904565, AB4967214, AB5004557, AB5034303 |
| Model numbers | 254400525 |
Product
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
Reason for recall
Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
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-1419-2022. 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.