—#130144

Product

ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog NOs. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 ABC4113 C4113 ABC50741 C50471 254400521 ABB13662 B13662 ABB19116 B19116 ABB19117 B19117 ABB19118 B19118 ABB35392 B35392 ABB35393 B35393 ABB39835 B39835 ABB41384 B41384 ABB46872 B46872 ABB49200 B49200 ABB50724 B50724 ABB55749 B55749 ABB63598 B63598 ABB66346 B66346 ABB72107 B72107 ABB77183 B77183 ABB79390 B79390 ABB79391 B79391 ABB80712 N80712 ABC17165 C17165 ABC5023 C5023

Why it was recalled

Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.

Root cause (FDA determination)

Process control

Action the firm took

DePuy sent an "URGENT DEVICE CORRECTION" notifications dated October 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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 call 574-371-4917.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, UAE, United Kingdom and Chile.

Timeline

Recall initiated: 2014-10-15
Posted by FDA: 2014-11-10
Terminated: 2015-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130144. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.