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V. Mueller
STERIS CORPORATION · Model RA1542 · UDI-DI 10885403110795
GFJ
Prescription
3
510(k) clearances
17
Adverse events
2
Recalls
176
Facilities
Description
Affinity COTTLE MALLET NYLON FACE REPLACEMENT FOR RA1541
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-11 | Smith & Nephew, Inc. | 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 |
| 2017-02-20 | Signal Medical Corporation | Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip mus |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.