Recalls / —

—#179099

Product

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

FDA product code

HTZ — Instrument, Cutting, Orthopedic

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K043223

Affected lot / code info

Lot SO2040929 ***Updated 7/9/20*** Lot SO2040602 Lot SO2037408 (None of this lot distributed in the US / OUS distribution only)

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

DePuy Orthopaedics, Inc.

Address

700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern

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

Timeline

Recall initiated

2020-01-03

Posted by FDA

2020-02-13

Terminated

2021-08-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #179099. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.