DePuy Orthopaedics, Inc. SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Brand
DePuy Orthopaedics, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot SO2040929 ***Updated 7/9/20*** Lot SO2040602 Lot SO2037408 (None of this lot distributed in the US / OUS distribution only)
DePuy Orthopaedics, Inc. is recalling SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting blo due to The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IA, MA, NY, OH, PA
Page updated: Jan 10, 2026