Recall Z-0878-2020— Smith & Nephew, Inc.

Name: FDA recall Z-0878-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-16

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2019-12-16. It names one FDA 510(k) clearance: K121393. 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).. Reason: Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-12-16
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K121393 — SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.·cleared 2012-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.