Zimmer Trabecular Metal Technology, Inc.: 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,

Is my product affected?

00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 007205

• UPC 00720504022
• UPC 00720504222
• UPC 00720504622
• UPC 00720504828
• UPC 00720505228
• UPC 00720505628
• UPC 00720505828
• UPC 00720506028
• UPC 00720506228
• UPC 00720506428
• UPC 00721004222
• UPC 00721004422
• UPC 00721005028
• UPC 00721005228
• UPC 00721005628
• UPC 00721006428
• UPC 00721006628
• UPC 00721006828
• UPC 00721007028
• UPC 00725504222
• UPC 00725504622
• UPC 00725504626
• UPC 00725504828
• UPC 00725505232
• UPC 00725505432
• UPC 00725505632
• UPC 00725505828
• UPC 00725505832
• UPC 00725506028
• UPC 00725506032
• UPC 00725506228
• UPC 00725506232
• UPC 00725506428
• UPC 00725506432
• UPC 00725506628
• UPC 00725506632
• UPC 00725506828
• UPC 00725506832
• UPC 00725507028
• UPC 00725507032

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet is recalling 19,884 sterile Trabecular Metal acetabular cup implants distributed nationwide and internationally. The implants were manufactured between April 2011 and October 2012 and came in foil pouches designed to maintain sterile integrity as part of a dual barrier system. The recall affects multiple product codes and lot numbers of these hip replacement components.

The recall notice does not specify a remedy or recommended course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

Details from the source

Reason for recall: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity. Distribution: Nationwide and Foreign. Quantity: 19,884 total Lot/code info: 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 61868161 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 62075682 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 61868174 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 62099999 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 61985379 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 61739647 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 61859335 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 61868180 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 61885454 61912432 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 61763307 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 62075683 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 61792574 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 61747148 61770547 61859658 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 61747106 61812211 61830726 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 62020209 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 61836505 61855146 61954911 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 61830949 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 61885408 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 61830844 61859307 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 61770545 61804351 61763316 61786342 61786341 61804383 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 61770407 61804495 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 61836909 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 61947556 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 61747107 61763580 61786278 61830727 61859504 61859551 61879091 61879090 61912430 62002120 62075898 62100011 62115299 00725505432 ACET CUP, 0 DEG,

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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