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KIATO PLUS
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED · Model 20 · UDI-DI 08902895182200
10
510(k) clearances
970
Adverse events
13
Recalls
304
Facilities
Description
KIATO PLUS Sterile Carbon Steel Rib Back Surgical Blade Box of 100 size 20. Sterilized by Gamma irradiation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-27 | Southmedic, Inc. | Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold |
| 2016-06-27 | Aspen Surgical Puerto Rico Corp. | After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil |
| 2012-08-15 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Potential for bent tips. |
| 2012-08-15 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Potential for bent tips. |
| 2012-08-15 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Potential for bent tips. |
| 2012-08-15 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Potential for bent tips. |
| 2009-09-29 | Merit Medical Systems, Inc. | Potential sterility breach caused by excessive shipment damage. |
| 2008-11-17 | Miltex, Inc. | Blade may break: Over milling of the blade resulted in tip more narrow than specified. |
| 2007-08-10 | Becton Dickinson & Company | Complaints received of rust on the blades of BD Bard-Parker Surgical blades. |
| 2007-08-10 | Becton Dickinson & Company | Complaints received of rust on the blades of BD Bard-Parker Surgical blades. |
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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.