FDA (Devices) recall action 82642
The FDA (Devices) publishes a recall like this one as 76 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 76 pages.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The agency’s own wording, quoted from the enforcement report.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.
Zimmer GmbH is recalling specific 3.5mm screw drills because they may be made from a different material than specified.
Zimmer GmbH is recalling V-TEK Micro-countersink items because they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific cannulated orthopedic screws because an investigation found they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling 2.5x135mm AO Drills because they may be made from a different material than specified. The products were distributed to 41 US states.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.
Zimmer GmbH is recalling CBS 4.5 countersinks because they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific AO drills because they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific cannulated drills because an investigation found they may have been manufactured from a different material than defined in specifications.
Zimmer GmbH is recalling contra-angle drills that may have been manufactured from a different material than specified. The products were distributed to 41 US states.
Zimmer GmbH is recalling V-TEK micro-countersinks because an investigation found they may be made from a different material than specified.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a different material than specified. The products were distributed to 41 US states.
Zimmer GmbH is recalling Drill Sys 2.7 units because they may have been manufactured from a material different from specifications.
Zimmer GmbH is recalling Stryker 2.5x94mm Drills because an investigation found they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.
Zimmer GmbH is recalling V-TEK standard-countersink cannulated AO screws because they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.
Zimmer GmbH is recalling CBS micro, countersink, cannulated, AO screws (Item Number ST503004541) because they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.
Zimmer GmbH is recalling Stryker 26mm drills because an investigation found they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling 2.7x125mm AO drills because they may be made from the wrong material. The devices were distributed to 40 US states.
Zimmer GmbH is recalling specific orthopedic drills because they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific AO orthopedic drills because they may be made from the wrong material. The products were distributed to 39 US states.
Zimmer GmbH is recalling V-TEK IVP step drills because they may have been manufactured from a material different from the applicable specifications.
Zimmer GmbH is recalling 2.7mm AO surgical drills because they may have been manufactured from a material different from specifications.