smith&nephew PROFIX Mallet — Class II medical device recall Z-0696-2020
Terminated recall by Smith & Nephew, Inc., reported 2019-12-25, distributed nationwide. There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet
| Recall number | Z-0696-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2019-11-11 |
| Classified | 2019-12-17 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2021-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, CA, CH, CN, CR, DE, FI, FR, GB, HK, IT, NL, NO, PA, PL, VE |
| Quantity | 1,371 devices |
| Lot numbers | 17AM17766, 17AM17767, 17CM01798, 17CM01799, 17CM01800, 17CM01801, 17CM01802, 17CM01803, 17CM01804, 17CM01805, 17CM01806, 17CM01807, 17CM02636, 17CM02637, 17CM02638, 17CM02639, 17CM02640, 17CM02641, 17CM02641A, 17CM02642, 17CM02643, 17CM02644, 17CM02645, 17CM02646, 17CM02647, 17CM02648, 17CM05047, 17CM05048, 17CM05049, 17CM05050, 17CM05050A, 17CM05051, 17CM05052, 17CM05053, 17CM05054, 17CM05055, 17CM05056, 17CM05057, 17CM05058, 17CM05059 and 140 more |
| Model numbers | 71512452 |
Product
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
Reason for recall
There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.
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-0696-2020. 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.