Recall Z-2163-2018— Smith & Nephew, Inc.

Name: FDA recall Z-2163-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-04

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2018-05-04, terminated 2019-02-22. It names one FDA 510(k) clearance: K121393. Product: smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1). Reason: One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Terminated: 2019-02-22
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 GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

Reason for recall

One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

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