Recall Z-0199-2015 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Orthopaedics, Inc.
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
| Date | Nov 10, 2014 (initiated Oct 15, 2014) |
| Status | Terminated |
| Reason | 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 | Process control |
| 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. |
| Quantity | 3,082 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.