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Reason: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

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.

Distribution pattern: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.