REFLECTION — Class II medical device recall Z-1008-2017
Terminated recall by Smith & Nephew, Inc., reported 2017-01-18, distributed nationwide. The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of t
| Recall number | Z-1008-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2016-11-16 |
| Classified | 2017-01-11 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2019-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, BR, CA, CH, CN, CO, CR, DE, DK, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, MX, MY, NL, NO, PL, PT, SE, SG, TH, TR, VE, ZA |
| Quantity | 4,444 units |
| Reason classes | packaging |
| Model numbers | 71362106 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1008-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.