Recall Z-1008-2017— Smith & Nephew, Inc.

Name: FDA recall Z-1008-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-16

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2016-11-16, terminated 2019-08-19. It names one FDA 510(k) clearance: K123598. Product: REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116. Reason: The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-16
Terminated: 2019-08-19
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K123598 — SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.·cleared 2013-06-28

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

REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116

Reason for recall

The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

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