The ATTUNE INTUITION Impaction Handle is a re-useable instrument… — Class II medical device recall Z-0953-2015
Terminated recall by DePuy Orthopaedics, Inc., reported 2015-01-21, distributed nationwide. Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If
| Recall number | Z-0953-2015 |
|---|---|
| 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 | 2015-01-12 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-12-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, ES, FR, GB, HK, IE, IL, IN, IT, JP, KR, MY, NL, NZ, SA, SG, SK, TH, ZA |
| Quantity | 7,944 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10603295423324 |
| Model numbers | 2544-01-017 |
Product
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the purpose of impaction, extraction, and insertion applications at steps within the surgical procedure. Due to the frequency of its use, two impaction handles are supplied in each kit.
Reason for recall
Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery.
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-0953-2015. 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.