FDA (Devices) recall action 68656
The FDA (Devices) publishes a recall like this one as 16 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 16 pages.
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles that may fail to remain assembled during use.
Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handles may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 units of VER2 DBL OFFSET RASP HANDLE, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, RT Nonsterile because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 nonsterile VER2 D8L Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 units of nonsterile orthopedic rasps because the handle may fail to remain assembled during use.
Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain attached to the rasp during use.
Zimmer, Inc. is recalling 412 units of VER2 Handle, Pin Rework, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 units of nonsterile VI DBL OFFST W/ LRG STPL, LT rasps because the handle may fail to remain assembled during use.
Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.