Zimmer, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1694-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 29, 2015

Date Posted: June 10, 2015

Recall Number: Z-1694-2015

Event ID: 71243

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.

Status: Terminated

Product Quantity: 289,616

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated