—#136987

Product

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

FDA product code: NDJ — Screw, Fixation, Bone, Non-Spinal, Metallic
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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.

Timeline

Recall initiated: 2015-04-29
Posted by FDA: 2015-05-29
Terminated: 2015-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.