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MSI

Modern Surgical Instruments LLC · Model 18-5002 · UDI-DI 00810130207206

FFO Prescription

510(k) clearances

Adverse events

Recalls

152

Facilities

Description

SL Basic Retractor and Distraction System with tray includes 18-5012 SL Transverse Retractor Lateral Feed Opening Width 150mm (1), 00810130200603 18-5005 SL Longitudinal Retractor Frame lateral feed (1), UDI 00810130201129 18-6060 SL Color Coded Depth Gauge (1), UDI 00810130200757 17-4120 Caspar Spinal Spreader, Right, Rack 130mm (1), UDI 00810130200658 17-4105 Caspar Spinal Spreader, Left, Rack 130mm (1), UDI 00810130200672 17-4623 Caspar Screwdriver with black Radel handle (PPSU) (2), UDI 00810130200733 17-4422 Drill Guide for Caspar Spinal Spreader Left with Black Radel Handle 16 x 20mm (1), UDI 00810130200719 17-4424 Drill Guide for Caspar Spinal Spreader Right with Black Radel Handle 16 x 20mm (1), UDI 00810130200726 17-4802 Caspar spinal spreader Twist Drill long drill length 14 mm, shaft Ø 8 mm total length 148 mm (1), UDI 00810130204182 18-5020 SL Locking Retractor Handle, lateral feed (1), UDI 00810130200702 29-6894 Tray with inlays SL ACF, 540 X 253 X 170mm (1), UDI 00810130200740 18-5130 SL Tissue Blade 30mm Blunt, Silver, anodized Natural (2), UDI 00810130200764 18-5135 SL Tissue Blade 35mm Blunt Anodized Dark Blue (2), UDI 00810130200771 18-5140 SL Tissue Blade 40mm Blunt Anodized Dark Red (2), UDI 00810130200788 18-5145 SL Tissue Blade 45mm Blunt Anodized Olive Green (2), UDI 00810130200795 18-5150 SL Tissue Blade 50mm Anodized Dark Violet (2), UDI 00850017626119 18-5155 SL Tissue Blade 55mm Blunt Anodized Black (2), UDI 00810130200801 18-5160 SL Tissue Blade 60mm Blunt Anodized Dark Gold (2), UDI 00810130200818 18-5165 SL Tissue Blade 65mm Blunt Anodized Titanium (2), UDI 00810130200825 18-5170 SL Tissue Blade 70mm Blunt Anodized Yellow (2), UDI 00810130200832 18-5175 SL Tissue Blade 75mm Blunt Anodized Dark Orange (2), UDI 00810130200849 18-5330 SL Medial Muscle Blade 30mm Long Teeth Anodized Natural (1), UDI 00810130200931 18-5335 SL Medial Muscle Blade 35mm Long Teeth Anodized Dark Blue (1), UDI 00810130200948 18-5340 SL Med

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.