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MSI

Modern Surgical Instruments LLC · Model 769-01 · UDI-DI 00810130206209

FFO Prescription

510(k) clearances

Adverse events

Recalls

152

Facilities

Description

BB System Complete Titanium includes: 769-07 BB Retractor Right (1) UDI 00810130200009 769-12 BB Retractor Left (1) UDI 00810130200016 769-17 BB Retractor Offset (1) UDI 00810130200023 769-83 BB Long Rack (1) UDI 00810130200030 769-35 Handle (2) UDI 00810130200047 769-37 Depth Gauge (1) UDI 00810130200054 769-92 Spike Blade (1) UDI 00810130200061 769-95 T-Blade (1) UDI 00810130200078 769-97 Blade (1) UDI 00810130200085 769-91 Instrument Clutch (1) UDI 00810130200092 968-77 Sterilizing Instrument Case with Lid UDI 00810130200108 BB Blades with Teeth 22.5mm x 34mm thru 70mm (2 ea) 769-50 00810130200115 769-51 00810130200122 769-52 00810130200139 769-53 00810130200146 769-54 00810130201372 769-55 00810130200153 769-57 00810130200160 769-59 BB Blade with Teeth 22.5mm x 85mm (1) UDI 00810130200177 769-60 thru 769-67 BB Blades Blunt 22.5mm x 34mm thru 70mm (2 ea) 769-60 00810130200184 769-61 00810130200191 769-62 00810130200207 769-63 00810130200214 769-64 00810130200221 769-65 00810130200238 769-67 00810130200245 769-40 thru 769-42 BB Blades with Teeth 26.5mm x 40mm thru 55mm (4 ea) 769-40 00810130200252 769-41 00810130200269 769-42 00810130200276 769-45 thru 769-47 BB Blades Blunt 26.5mm x 40mm thru 55mm (2 ea) 769-45 00810130200283 769-46 00810130200290 769-47 00810130200306

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.