Z-1169-2020 Class II Terminated
FDA device recall Z-1169-2020 was initiated by DePuy Orthopaedics, Inc. on January 3, 2020 and is designated Class II. Reason for recall: The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery. The recall status is terminated (terminated August 12, 2021). Affected quantity: 140 total units.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- January 3, 2020
- Termination Date
- August 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 140 total units
Product Description
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Reason for Recall
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
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
Code Information
Lot SO2040929 ***Updated 7/9/20*** Lot SO2040602 Lot SO2037408 (None of this lot distributed in the US / OUS distribution only)