Recall Z-1921-2018— Smith & Nephew, Inc.

Name: FDA recall Z-1921-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-02

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2018-05-02, terminated 2020-09-01. It names one FDA 510(k) clearance: K052792. Product: smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.. Reason: Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Terminated: 2020-09-01
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K052792 — ANTHOLOGY HIP STEMSmith & Nephew, Inc.·cleared 2005-10-07

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 ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.

Reason for recall

Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.

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