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

Recall number

Z-1694-2015

Recalling firm

Zimmer, Inc.

Product

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

Status

Terminated

Initiated

2015-04-29

Posted

2015-05-29

Terminated

2015-12-08

Reason

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.

Root cause

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

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

NDJ

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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