Recall Z-0878-2020
Smith & Nephew, Inc. · initiated December 16, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: 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.
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.
FDA-determined cause: Process change control
Action taken
The firm initiated the recall by letter on December 16, 2019. The letter identified the problem and directed the consignee to remove the affected lots noted in the Urgent Medical Device Recall Notice.
Details
- Recall number
- Z-0878-2020
- Initiated
- December 16, 2019
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Quantity
- 59 units
- Distribution
- USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN