Cortical Screw for M/DN Intramedullary Fixation. recall
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Why was Cortical Screw for M/DN Intramedullary Fixation. recalled?
The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing.
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?
All lots. Part numbers: 00-2253-020-45 INTERLOCKING IM SCREW 4.5MM DIA X 20MM 00-2253-022-45 INTERLOCKING IM SCREW 4.5MM DIA X 22.5MM 00-2253-025-45 INTERLOCKING IM SCREW 4.5MM DIA X 25MM 00-2253-027-45 M/DN Intramedullary Fixation 4.5mm Dia. Cortical Screw 00-2253-030-45 INTERLOCKING IM SCREW 4.5MM DIA X 30MM 00-2253-032-45 INTERLOCKING IM SCREW 4.5MM DIA X 32.5MM 00-2253-035-45 INTERLOCKING IM SCREW 4.5MM DIA X 35MM 00-2253-037-45 INTERLOCKING IM SCREW 4.5MM DIA X 37.5MM 00-2253-040-45 INTERLOCKING IM SCREW 4.5MM DIA X 40MM 00-2253-042-45 INTERLOCKING IM SCREW 4.5MM DIA X 42.5MM 00-2253-045-45 INTERLOCKING IM SCREW 4.5MM DIA X 45MM 00-2253-047-45 INTERLOCKING IM SCREW 4.5MM DIA X 47.5MM 00-2253-050-45 INTERLOCKING IM SCREW 4.5MM DIA X 50MM 00-2253-052-45 INTERLOCKING IM SCREW 4.5MM DIA X 52.5MM 00-2253-055-45 INTERLOCKING IM SCREW 4.5MM DIA X 55MM 00-2253-057-45 INTERLOCKING IM SCREW 4.5MM DIA X 57.5MM 00-2253-060-45 INTERLOCKING IM SCREW 4.5MM DIA X 60MM 00-2253-062-45 INTERLOCKING IM SCREW 4.5MM DIA X 62.5MM 00-2253-065-45 INTERLOCKING IM SCREW 4.5MM DIA X 65MM 00-2253-067-45 INTERLOCKING IM SCREW 4.5MM DIA X 67.5MM 00-2253-070-45 INTERLOCKING IM SCREW 4.5MM DIA X 70MM 00-2253-072-45 INTERLOCKING IM SCREW 4.5MM DIA X 72.5MM 00-2253-075-45 INTERLOCKING IM SCREW 4.5MM DIA X 75MM 00-2253-077-45 INTERLOCKING IM SCREW 4.5MM DIA X 77.5MM 00-2253-080-45 INTERLOCKING IM SCREW 4.5MM DIA X 80MM 00-2253-082-45 INTERLOCKING IM SCREW 4.5MM DIA X 82.5MM 00-2253-085-45 INTERLOCKING IM SCREW 4.5MM DIA X 85MM 00-2253-087-45 INTERLOCKING IM SCREW 4.5MM DIA X 87.5MM 00-2253-090-45 INTERLOCKING IM SCREW 4.5MM DIA X 90MM
- Product
- Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
- Recalling firm
- Zimmer, Inc.
- Quantity
- 289,616
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada, Brazil, Mexico, Bahamas, Nicaragua, Singapore, China, Japan, Malaysia, Taiwan, Thailand, Korea, Spain, Belgium, Switzerland, India, Germany, England, Italy, Saudi Arabia, Lebanon, Libya, United Arab Emirates, Algeria, France, United Kingdom, Canary Islands, Iraq, Jordan, Lithuania, Morocco, Macedonia, Malta, Mauritius, Serbia, Russian Federation, and Yemen.
- Recall date
- June 10, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)