Specialist 2 Distal Femoral Cutting Block recall
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Why was Specialist 2 Distal Femoral Cutting Block recalled?
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot SO2040929 ***Updated 7/9/20*** Lot SO2040602 Lot SO2037408 (None of this lot distributed in the US / OUS distribution only)
- Product
- SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 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, France, Germany, Maldives, New Zealand, and UAE
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)