SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
This recall has been terminated (originally issued February 13, 2020).
- Company
- Depuy Orthopaedics, Inc.
- Recall Initiated
- January 3, 2020
- Posted
- February 13, 2020
- Terminated
- August 12, 2021
- Recall Number
- Z-1169-2020
- Quantity
- 140 total units
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
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
Lot / Code Info
Lot SO2040929 ***Updated 7/9/20*** Lot SO2040602 Lot SO2037408 (None of this lot distributed in the US / OUS distribution only)
Root Cause
Process control
Action Taken
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 receipt of this notification. 4. Forward this notice to anyone in your facility that needs to be informed, including surgeons who may have used this product. 5. If any impacted products have been forwarded to another facility, contact that facility and provide them with this letter. For clinical questions from surgeons, please contact DePuy Synthes Scientific and Medical Affairs mailbox RA-DPYUS-DePSynSc@ITS.JNJ.com. ***Updated 7/9/2020*** Firm sent out new notifications dated July 13, 2020 communicating that event has expanded to include two additional lots.