Z-0535-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2014
- Initiation Date
- September 8, 2014
- Termination Date
- November 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 trocars
Product Description
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Code Information
1) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, lg, 12 mm; Symmetry Surgical Item Number: 54-7004; Lot Numbers: 050213, 100410. 2) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: CareFusion; CareFusion Product Name: Nelson Patterson Trocar, lg, 12 mm; CareFusion Item Number: VM72-3111; Lot Number: 050213. 3) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Symmetry Surgical Item Number: 54-7005; Lot Number: 060312. 4) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Ambler Surgical Item Number: 95-203; Lot Number: 100410. 5) Instrumed Product Name: Nelson Patterson Trocar, med, 1.5 mm; Instrumed Product Number: 500-01948; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med, 1.5 mm; Symmetry Surgical Item Number: 54-7006; Lot Number: 100410. 6) Instrumed Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Instrumed Product Number: 500-01953; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Symmetry Surgical Item Number: 54-7007; Lot Number: 030312.