Recall Z-1028-2019— Smith & Nephew, Inc.

Name: FDA recall Z-1028-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-19

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2019-02-19, terminated 2021-05-21. It names one FDA 510(k) clearance: K103256. Product: smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510. Reason: Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1".

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-02-19
Terminated: 2021-05-21
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K103256 — SMITH & NEPHEW SMF HIP STEMSmith & Nephew, Inc.·cleared 2011-01-31

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 SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510

Reason for recall

Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

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