FDA (Devices) recall action 68017
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
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 546 units of Hinged Knee Supports because raw material labeled as latex-free actually contained latex.
Zimmer, Inc. is recalling 649 units of Neoprene Tennis Elbow Supports because raw material labeled as latex-free actually contained latex.
Zimmer, Inc. is recalling 2,222 units of Cartilage Knee Braces because raw material labeled as latex-free actually contained latex.
Zimmer, Inc. is recalling Drop Lok Knee Braces because raw material labeled as latex-free was found to contain latex. The recall affects 131 units distributed in the US and internationally.