Rotating Tibial Platform ATTUNE INTUITION Impactor — Class II medical device recall Z-0904-2015
Terminated recall by DePuy Orthopaedics, Inc., reported 2015-01-14, distributed nationwide. ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small piec
| Recall number | Z-0904-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-11-10 |
| Classified | 2015-01-05 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-12-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CN, ES, FR, GB, IE, IL, IN, IT, JP, KR, MY, NL, NZ, SG, SK, TH, ZA |
| Quantity | 3,861 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10603295130208 |
Product
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
Reason for recall
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Machine access
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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.