FDAClass IIAugust 27, 2014

Magna-Fx Cannulated Screw Fixation System Bone Screw recall

Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer

Why was Magna-Fx Cannulated Screw Fixation System Bone Screw recalled?

Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

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?

Item Number 00-1146-030,035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, -99

Product
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
Recalling firm
Zimmer, Inc.
Quantity
47,682 units total
Distribution
National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
Recall date
August 27, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls