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Terminated

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

FDA Recall Z-0199-2015 · Posted 2014-11-10

Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-10-15
Date Terminated2015-11-19
Product Quantity3,082

Reason for Recall

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.

Firm Action

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.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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