Severe FDA (Devices)·Z-1008-2017·Announced 2017-01-18

Smith & Nephew Recalls Reflection Dead Blow Mallets Due to Weld Cracks

Smith & Nephew is recalling Reflection Dead Blow Mallets because cracks in the weld allowed lead beads to escape into surgical wounds.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves the release of lead particles into surgical wounds, which constitutes a significant injury risk and potential for serious harm.

Plain-English summary

Smith & Nephew, Inc. is recalling 4,444 units of the Reflection Dead Blow Mallet (REF 71362106). The recall was initiated after the firm received complaints regarding 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. The affected units were distributed worldwide, including the United States (nationwide), Puerto Rico, and numerous international locations.

Healthcare facilities and consumers should stop using the affected mallets immediately. Users should check their inventory for the specific lot codes listed in the official recall notice and contact Smith & Nephew for instructions on return or replacement.

The recalled product

Product: REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Surgical Instrument
Hazard: lead-exposure
foreign-body-contamination
Affected units: 4,444

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

606861
606862
606863
606864
701432
701433
808421
808422
1200840
50903653
60708545
60806634
61005467
70704991
70907344
71002434
71106654
71106655
80603593
80603594

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Smith & Nephew, Inc.

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Same hazard · lead exposure