—#132113

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: CATALOG NO. : 2544-01-017 LOT NUMBER: All Lots Barcode GTIN: 10603295423324

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

On 11/10/2014, URGENT INFORMATION ATTUNE INTUITION IMPACTION HANDLE AND IMPACTORS DEVICE CORRECTION NOTICE notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Worldwide Distribution-US (nationwide) except AK and RI, including PR and the countries of Chile, Canada, Australia, Austria, Belgium, France, Hong Kong, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK

Timeline

Recall initiated: 2014-11-10
Posted by FDA: 2015-01-12
Terminated: 2015-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132113. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.