Recall Z-0905-2015 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Orthopaedics, Inc.
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (25440100
| Date | Jan 5, 2015 (initiated Nov 10, 2014) |
| Status | Terminated |
| Reason | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient. |
| Root cause | Device Design |
| Action | DePuy Synthes sent an Urgent Information letter dated November 10, 2014, to all affected customers. 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. Customers were instructed to complete the Hospital/User Facility Acknowledgement Car and return to their Deputy Orthopaedics Sales Consultant or fax to 574-371-4939. Customer swere also asked to retain a copy of the complete Acknnowlegement Card in their files along with the notice. Customers with questi |
| Quantity | 4661 |
| Distribution | Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Th |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.