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- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5m...

FDA Device Recall #Z-1631-2013 — Class II — May 3, 2013

Recall Summary

Recall Number Z-1631-2013
Classification Class II — Moderate risk
Date Initiated May 3, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Surgical Instrument Service And Savings, Inc.
Location Redmond, OR
Product Type Devices
Quantity 30

Product Description

- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For Modular Hand System, Quick Coupling 2.8mm x 165mm Ref. 310.288 Lot 122322 - Drill Bit, Quick Coupling (Gold) 2.5mm Ref. DB-2.5 Lot 122289, 122322 - Egg Micro Bur, 10 Flute, Stainless Steel 4.0mm Ref. 1608-2-35 Lot 122429, 122347 - Hall Micro Bur, Oval, Long, 8-Flute, Carbide 4.0mm x 8.0mm Ref. 5092-136 Lot 123353 - Micro Bur, Round, Stainless Steel 3.2mm Ref. 1608-2-11 Lot 122447, 122347 - Oval Bur, Fast Cutting, 8-Flutes, Carbide, 44.5mm Total Length, 18.6mm Exposure 4.0mm x 7.9mm Ref. 227-10-62 Lot 122411 - Oval Bur, Solid, 8-Flute, Medium, Head Length: 7.7mm, Carbide 4.0mm x 48mm Ref. 5300-10-901 Lot 122647 - Oval Cutting Carbide Bur, Medium, (8-Flute) 4.0mm Ref. 5091-136 Lot 123353, 122454 - Round Bur, Medium, Solid 8-Flute, Carbide 4.0mm x 48.3mm Ref. 5300-10-511 Lot 122665 - Round Bur, Micro, 8-Flute, Exposure: 28.2mm Stainless Steel 2.4mm x 54mm Ref. 1608-2-9 Lot 122447 - Twist Drill, Quick Coupling 110mm 2.5mm Ref. 310.25 Lot 122289, 122322 - Wire Pass Drill Bit 1.5mm Ref. 1608-2-59 Lot 122511 Surgical instrument motors and accessories/attachments

Reason for Recall

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Distribution Pattern

Nationwide Distribution.

Lot / Code Information

122347, 122454, 122411, 122289, 123353, 122429, 122322, 122447, 122665, 122647, 122511.

Other Recalls from Surgical Instrument Service And Savin...

Recall # Classification Product Date
Z-1639-2013 Class II - Relieva Flex Sinus Guide Catheter (Green) Tip... May 3, 2013
Z-1641-2013 Class II - CLEAR-TRAC COMPLETE, Threaded Cannula with Ob... May 3, 2013
Z-1627-2013 Class II -Scorpion Needle, For Use With Scorpion Suture ... May 3, 2013
Z-1623-2013 Class II -Instratek Carpal Tunnel Release Blades, (1) Tr... May 3, 2013
Z-1638-2013 Class II - Calf Garment Standard Ref. L501-M Lot 122549... May 3, 2013

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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