Recall Z-2624-2017— Smith & Nephew, Inc.

Name: FDA recall Z-2624-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-30

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-05-30, terminated 2021-12-10. It names one FDA 510(k) clearance: K162775. Product: LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM. Reason: The incorrect Loctite adhesive was used to assemble the impactor heads..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-30
Terminated: 2021-12-10
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K162775 — Legion Cone SystemSmith & Nephew, Inc.·cleared 2017-01-13

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

LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

Reason for recall

The incorrect Loctite adhesive was used to assemble the impactor heads.

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