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0.85 mm serrated punch, 5 pack
Cole Instruments Inc · Model IHTI-0.85-2S-094 punch · UDI-DI 00810072350305
7
510(k) clearances
756
Adverse events
6
Recalls
251
Facilities
Description
0.85 mm serrated punch, 5 pack
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-10-23 | Alto Development Corp | Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility. |
| 2016-01-08 | DePuy Orthopaedics, Inc. | Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may r |
| 2013-03-18 | Clorox Healthcare Holdings, LLC (dba HealthLink) | Due to lack of sterilization. |
| 2013-03-18 | Clorox Healthcare Holdings, LLC (dba HealthLink) | Due to lack of sterilization. |
| 2013-03-18 | Clorox Healthcare Holdings, LLC (dba HealthLink) | Due to lack of sterilization. |
| 2012-08-14 | Biomet, Inc. | Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to p |
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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.