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MSI

Modern Surgical Instruments LLC · Model 769-03 · UDI-DI 00810130206018

FFO Prescription

510(k) clearances

Adverse events

Recalls

152

Facilities

Description

769-07 BB Retractor Right (Titanium) UDI 00810130200009 769-12 BB Retractor Left (Titanium) UDI 00810130200016 769-17 BB Retractor Offset (Titanium ) UDI 00810130200023 769-35 Blade Inserting Handle UDI 00810130200047 769-50 BB Blade with Teeth (Titanium) 22.5mm x 34mm UDI 00810130200115 769-51 BB Blade with Teeth (Titanium) 22.5mm x 40mm UDI 00810130200122 769-52 BB Blade with Teeth (Titanium) 22.5mm x 45mm UDI 00810130200139 769-53 BB Blade with Teeth (Titanium) 22.5mm x 50mm UDI 00810130200146 769-54 BB Blade with Teeth (Titanium ) 22.5mm x 55mm UDI 00810130201372 769-55 BB Blade with Teeth (Titanium) 22.5mm x 60mm UDI 00810130200153 769-57 BB Blade with Teeth (Titanium) 22.5mm x 70mm UDI 00810130200160 769-60 BB Blunt Blade (Titanium) 22.5mm x 34mm UDI 00810130200184 769-61 BB Blunt Blade (Titanium) 22.5mm x 40mm UDI 00810130200191 769-62 BB Blunt Blade (Titanium) 22.5mm x 45mm UDI 00810130200207 769-63 BB Blunt Blade (Titanium) 22.5mm x 50mm UDI 00810130200214 769-64 BB Blunt Blade (Titanium) 22.5mm x 55mm UDI 00810130200221 769-65 BB Blunt Blade (Titanium) 22.5mm x 60mm UDI 00810130200238 769-67 BB Blunt Blade (Titanium) 22.5mm x 70mm UDI 00810130200245 769-40 BB Blade with Teeth (Titanium) 26.5mm x 40mm UDI 00810130200252 769-41 BB Blade with Teeth (Titanium) 26.5mm x 47mm UDI 00810130200269 769-42 BB Blade with Teeth (Titanium) 26.5mm x 55mm UDI 00810130200276 769-45 BB Blunt Blade (Titanium) 26.5mm x 40mm UDI 00810130200283 769-46 BB Blunt Blade (Titanium) 26.5mm x 47mm UDI 00810130200290 769-47 BB Blunt Blade (Titanium) 26.5mm x 55mm UDI 00810130200306 968-77 Sterilizing Instrument Case with Lid UDI 00810130200108

Recalls

Date	Firm	Reason
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2015-11-25	Abeon Medical Corporation	The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
2015-11-25	Abeon Medical Corporation	The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.

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Data 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.