Recall Z-1169-2020 ยท HTZ Instrument, Cutting, Orthopedic
DePuy Orthopaedics, Inc.
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
| Date | Feb 13, 2020 (initiated Jan 3, 2020) |
| Status | Terminated |
| Reason | The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery. |
| Root cause | Process control |
| Action | The recalling firm notified customers with emailed Urgent Recall Notices on January 3, 2020. The letter instructed customers to do the following: 1. Cease further distribution or use of the affected products and quarantine. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return and of any affected devices. Director Materials Management / Operating Room Supervisor / Risk Managers / Field Action Coordinators and Surgeons 3. Review, complete, sign and return the business reply form (BRF) to DePuy Synthes (DPYUS-JointReconFieldActions@its.jnj.com) within 5 business days of receip |
| Quantity | 140 total units |
| Distribution | Domestic distribution to IA, MA, NY, OH, and PA. Foreign distribution to Canada, China, Hungary, United Kingdom, and Singapore. ***Updated 7/9/20*** Expanded notice includes 6 new countries: Belgium, France, Germany, Maldives, New Zealand, and UAE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043223 | DEPUY CAS KNEE INSTRUMENTATION DePuy Orthopaedics, Inc., Mar 4, 2005 |