Recall Z-0532-2015
Instrumed International, Inc. · initiated September 8, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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)…
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
FDA-determined cause: No Marketing Application
Action taken
Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
Details
- Recall number
- Z-0532-2015
- Initiated
- September 8, 2014
- Posted by FDA
- December 16, 2014
- Terminated
- November 29, 2017
- Product code
- HDC – Tenaculum, Uterine
- Quantity
- 26 tenaculum hooks
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Recalling firm
- Instrumed International, Inc., Schaumburg, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0533-2015 Class II | An endometrial suction curette is a device used to remove material from the uterus and…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0534-2015 Class II | A zipser clamp is an instrument used to compress reduce blood flow to the penis and…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0535-2015 Class II | A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0536-2015 Class II | An external vein stripper is an extravascular device used to remove a section of a vein…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0537-2015 Class II | Manual bunnell cranial drills are bone cutting and drilling instruments that are used…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0538-2015 Class II | A circumcision clamp is an instrument used to compress the foreskin of the penis during…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0539-2015 Class II | Manual trephines are bone cutting and drilling instruments that are used without a power…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0540-2015 Class II | Hudson braces are bone cutting and drilling instruments that are used without a power…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0541-2015 Class II | Hudson cerebellar extensions are bone cutting and drilling instruments that are used…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0542-2015 Class II | Cushing perforating drills are bone cutting and drilling instruments that are used…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0543-2015 Class II | Cushing burrs are bone cutting and drilling instruments that are used without a power…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0544-2015 Class II | Hudson burrs are bone cutting and drilling instruments that are used without a power…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0545-2015 Class II | McKenzie Perforator Drills are bone cutting and drilling instruments that are used…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0546-2015 Class II | D'errico perforator drills are bone cutting and drilling instruments that are used…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0547-2015 Class II | McKenzie enlarging burrs are bone cutting and drilling instruments that are used without…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0548-2015 Class II | Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0549-2015 Class II | Galt trephines are bone cutting and drilling instruments that are used without a power…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0550-2015 Class II | Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0551-2015 Class II | Replacement screw non-springloaded traction tongs are skull tongs for traction used to…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0552-2015 Class II | Lock nuts for titanium traction tongs are used in traction skull tongs for traction used…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0553-2015 Class II | Titanium fixation screws, springloaded are used in traction skull tongs for traction…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0554-2015 Class II | Traction tong replacement screws, non-springloaded are used in traction skull tongs for…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0555-2015 Class II | Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0556-2015 Class II | CVB distraction screws are bone cutting and drilling instruments that are used without a…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0557-2015 Class II | Cloward Spanner gauges are bone cutting and drilling instruments that are used without a…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0558-2015 Class II | Tonometers are manual devices intended to measure intraocular pressure by applying a…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |
| Z-0559-2015 Class II | Schoitz weights are manual devices used with Schoitz tonometers and are intended to…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | 09/08/2014Terminated |