CVB distraction screws are bone cutting and drilling recall
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry…
Why was CVB distraction screws are bone cutting and drilling recalled?
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5106; Lot Number: 090109. 2) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Millennium Surgical Item Number: 57-5106; Lot Number: 090109. 3) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Medfix International Item Number: MF232-9052; Lot Numbers: 050214, 090109, 1290018. 4) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; CareFusion Item Number: VM84-3602; Lot Numbers: 090109. 5) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Boss Instruments; Boss Instruments Product Name: CVB Distraction Screw, pkg 5, 12 mm, Non-Sterile; Boss Instruments Item Number: 73-2591; Lot Numbers: 090109. 6) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5107; Lot Numbers: 020313, 090209. 7) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Millennium Surgical Item Number: 6-2878; Lot Numbers: 070109, 090109, 090209. 8) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medline Industries; Medline Industries Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medline Industries Item Number: MDG1108066; Lot Numbers: 020313, 090209. 9) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medfix International Item Number: MF232-9057; Lot Numbers: 020313, 050214, 090209. 10) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Surgical Direct; Surgical Direct Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Surgical Direct Item Number: SD145691.103; Lot Number: 090209. 11) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; CareFusion Item Number: VM84-3603; Lot Numbers: 020313, 090209. 12) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Distraction Screw CVD 14 mm; Teleflex Medical Item Number: P-22488; Lot Number: 090209. 13) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5108; Lot Numbers: 010114, 120408. 14) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Millennium Surgical Item Number: 6-2879; Lot Number: 120408. 15) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Medfix International Item Number: MF232-9062; Lot Number: 120408. 16) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; CareFusion Item Number: VM84-3604; Lot Number: 120408. 17) Instrumed Product Name: CVB Distraction Screw, 18 mm, Non-Sterile; Instrumed Product Number: 650-11486; Trade Name: Symmetry Surgical; Symmetry SurgicalProduct Name: CVB Distraction Screw, 18 mm, Non-Sterile; Symmetry SurgicalItem Number: 57-5100; Lot Numbers: 040109, 121610.
- Product
- CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry…
- Recalling firm
- Instrumed International, Inc.
- Quantity
- 790 distractor screws
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)