—#178599

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).

FDA product code: MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K121393
Affected lot / code info: 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.

Why it was recalled

Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.

Timeline

Recall initiated: 2019-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178599. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.