Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.

FDA device recall Z-1694-2015 · posted 2015-05-29 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

NDJ

Quantity affected

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, Ind

Date initiated

2015-04-29

Date posted

2015-05-29

Date terminated

2015-12-08

Location

Warsaw, IN