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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer M/DN Intramedullary Fixation Metaphyseal/Diaphyseal Nail System

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  Class 2 Device Recall Zimmer M/DN Intramedullary Fixation Metaphyseal/Diaphyseal Nail System see related information
Date Initiated by Firm April 29, 2015
Date Posted May 29, 2015
Recall Status1 Terminated 3 on December 08, 2015
Recall Number Z-1694-2015
Recall Event ID 71243
Product Classification Screw, fixation, bone, non-spinal, metallic - Product Code NDJ
Product Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Code Information 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
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
877-946-2761
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Component design/selection
Action Zimmer sent an Urgent Medical Device Recall letter dated April, 29, 2015, to all affected customers.On 4/29/2015. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate all affected product and quarantine them immediately. Return the recalled product along with completed Inventory Return Certification Form. Notify Zimmer of any further distribution of the affected product. In addition, identify the surgeons and hospitals that you have identified using the provided spreadsheet. For further questions call the customer call center at 1-877-946-2761.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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