Recall Z-1901-2024— Smith & Nephew Inc

Name: FDA recall Z-1901-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-24

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2024-04-24. It names 2 FDA 510(k) clearances: K022958, K021673. Product: smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4. Reason: Packaging contained the incorrect size of femoral head from what was displayed on the label..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-04-24
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K022958 — TOTAL HIP FEMORAL HEADS AND LINERSSmith & Nephew, Inc.·cleared 2002-10-02
K021673 — TOTAL HIP FEMORAL HEAD - 12/14 TAPERSmith & Nephew, Inc.·cleared 2002-06-11

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 OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4

Reason for recall

Packaging contained the incorrect size of femoral head from what was displayed on the label.

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