Recall Z-0200-2019— Smith & Nephew, Inc.

Name: FDA recall Z-0200-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-18

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2018-09-18, terminated 2019-05-08. It names one FDA 510(k) clearance: K121393. Product: Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.. Reason: One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-09-18
Terminated: 2019-05-08
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

Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.

Reason for recall

One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

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