SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.

FDA device recall Z-1169-2020 · posted 2020-02-13 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.

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.

Root cause

Process control

Status

Terminated

Product code

HTZ

Quantity affected

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,

Date initiated

2020-01-03

Date posted

2020-02-13

Date terminated

2021-08-12

Location

Warsaw, IN

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