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Terminated

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

FDA Recall Z-1169-2020 · Posted 2020-02-13

Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeHTZ
Date Initiated2020-01-03
Date Terminated2021-08-12
Product Quantity140 total units

Reason for Recall

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

Firm 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 ([email protected]) 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 [email protected]. ***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

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043223DEPUY CAS KNEE INSTRUMENTATIONDePuy Orthopaedics, Inc. · 2005-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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