A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold un...
FDA Device Recall #Z-0532-2015 — Class II — September 8, 2014
Recall Summary
| Recall Number | Z-0532-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 8, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Instrumed International, Inc. |
| Location | Schaumburg, IL |
| Product Type | Devices |
| Quantity | 26 tenaculum hooks |
Product Description
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
Reason for Recall
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Distribution Pattern
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Lot / Code Information
1) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm; CareFusion Item Number: VM29-7112; Lot Numbers: 07211, 100213. 2) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21113; Trade Name: TeleFlex Medical; Teleflex Medical Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Teleflex Medical Item Number: VM29-7112; Lot Number: 100213. 3) Instrumed Product Name: Emmet Tenaculum Hook, #2, blunt; Instrumed Product Number: 310-21113; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #2, blunt; CareFusion Item Number: VM29-71131X; Lot Number: 110110. 4) Instrumed Product Name : Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Emmet Tenaculum Hook, #5; Symmetry Surgical Item Number: 20-4205; Lot Number: 050412. 5) Instrumed Product Name: Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #5; CareFusion Item Number: GL804-001; Lot Number: 030313. 6) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; CareFusion Item Number: VM29-7112X; Lot Numbers: 110312, 110411. 7) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: EMMETT HOOK QUICK RELEASE, NO 1, BLUE RF COATED; CareFusion Item Number: GL805; Lot Numbers: 010214, 020314, 110312.
Other Recalls from Instrumed International, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0546-2015 | Class II | D'errico perforator drills are bone cutting and... | Sep 8, 2014 |
| Z-0534-2015 | Class II | A zipser clamp is an instrument used to compres... | Sep 8, 2014 |
| Z-0547-2015 | Class II | McKenzie enlarging burrs are bone cutting and d... | Sep 8, 2014 |
| Z-0548-2015 | Class II | Hudson cranial drill sets (w/ brace and 5 attac... | Sep 8, 2014 |
| Z-0550-2015 | Class II | Gardner-Wells traction tongs are skull tongs fo... | Sep 8, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.