Z-0878-2020 Class II Ongoing
FDA device recall Z-0878-2020 was initiated by Smith & Nephew, Inc. on December 16, 2019 and is designated Class II. Reason for recall: Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications. The recall status is ongoing. Affected quantity: 59 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- December 16, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units
Product Description
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).
Reason for Recall
Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
Distribution Pattern
USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.
Code Information
LEGION AP Cutting Block Size 4, Product Number 71434409, Lot Numbers: 17LM05399, 17LM07852, 17LM07852A; LEGION AP Cutting Block Size 6, Product Number 71434411, Lot Numbers: 17LM05397, 17LM05398, 17LM07849; LEGION AP Cutting Block Size 7, Product Number 71434412, Lot Numbers: 17LM01746, 17LM05390, 17LM05394, 17LM07851; LEGION AP Cutting Block Size 8, Product Number 71434413, Lot Number: 17LM08442.