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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer

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  Class 2 Device Recall Zimmer see related information
Date Initiated by Firm April 15, 2016
Create Date June 10, 2016
Recall Status1 Terminated 3 on November 29, 2017
Recall Number Z-1955-2016
Recall Event ID 73536
510(K)Number K964509  K980486  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product 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
00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM
00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM
00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM
00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM
00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM
00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM
00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM
00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM
00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM
00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM
00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM
00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM
00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM
00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM
00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM
00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM
00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM
00725505432 ACET CUP, 0 DEG, 32MM X 54MM
00725505632 ACET CUP, 0 DEG, 32MM X 56MM
00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM
00725505832 ACET CUP, 0 DEG, 32MM X 58MM
00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM
00725506032 ACET CUP, 0 DEG, 32MM X 60MM
00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM
00725506232 ACET CUP, 0 DEG, 32MM X 62MM
00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM
00725506432 ACET CUP, 0 DEG, 32MM X 64MM
00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM
00725506632 ACET CUP, 0 DEG, 32MM X 66MM
00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM
00725506832 ACET CUP, 0 DEG, 32MM X 68MM
00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM
00725507032 ACET CUP, 0 DEG, 32MM X 70MM
00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM
00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM
00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM


00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM
00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM
00726005432 ACET CUP, 10 DEG, 32MM X 54MM
00726005632 ACET CUP, 10 DEG, 32MM X 56MM
00726005832 ACET CUP, 10 DEG, 32MM X 58MM
00726006032 ACET CUP, 10 DEG, 32MM X 60MM
00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM
00726006432 ACET CUP, 10 DEG, 32MM X 64MM

00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM
00726006632 ACET CUP, 10 DEG, 32MM X 66MM
00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM
00726006832 ACET CUP, 10 DEG, 32MM X 68MM
00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM
00726007032 ACET CUP, 10 DEG, 32MM X 70MM
Code Information 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, 32MM X 54MM 61763443 61786289 61812220 61854565 61868305 61879040 61912416 61947555 61985264 62013146 62066591 62115776 00725505632 ACET CUP, 0 DEG, 32MM X 56MM 61763600 61804444 61912435 62002156 62039255 62062844 62062845 62115784 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 61804502 61837084 00725505832 ACET CUP, 0 DEG, 32MM X 58MM 62039086 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 61855145 00725506032 ACET CUP, 0 DEG, 32MM X 60MM 62075897 62100842 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 61770404 00725506232 ACET CUP, 0 DEG, 32MM X 62MM 62087671 62087672 62100008 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM 61804463 61854444 00725506432 ACET CUP, 0 DEG, 32MM X 64MM 62075673 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM 61885383 00725506632 ACET CUP, 0 DEG, 32MM X 66MM 62075875 62100005 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM 61885410 00725506832 ACET CUP, 0 DEG, 32MM X 68MM 62091779 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM 61830845 61859308 00725507032 ACET CUP, 0 DEG, 32MM X 70MM 62075857 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM 61804352 61812219 61786434 61804386 61763388 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM 61854356 61860438 61868209 62008764 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM 61747062 61804506 61859667 61878894 61947703 61976855 62002987 62039360 62063078 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM 61964956 62064122 62087681 62115304 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM 61747120 61763581 61786280 61792602 61879104 61912431 61947575 61985342 62002123 62008989 62039411 62075899 62062910 62087682 62100014 62115305 00726005432 ACET CUP, 10 DEG, 32MM X 54MM 61747076 61763450 61786291 61860512 61912417 61947554 61955257 61976866 61985266 62013145 62066592 62066593 62115775 62115774 00726005632 ACET CUP, 10 DEG, 32MM X 56MM 61786224 61854602 61860631 61912436 61976925 61976926 62002157 62009002 62020437 62063038 62115785 00726005832 ACET CUP, 10 DEG, 32MM X 58MM 62002962 62008999 62020376 62116069 00726006032 ACET CUP, 10 DEG, 32MM X 60MM 61912429 61985228 62002828 62008790 62054549  00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM 61762694 61860439 61860486 61885485 61947469 61976880 00726006432 ACET CUP, 10 DEG, 32MM X 64MM 62020184  00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM 61762674 61854537 00726006632 ACET CUP, 10 DEG, 32MM X 66MM 62020226 62100007 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM 61885411 62075884 00726006832 ACET CUP, 10 DEG, 32MM X 68MM 62095411 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM 61831011 61859310 61946201 00726007032 ACET CUP, 10 DEG, 32MM X 70MM 61976770
Recalling Firm/
Manufacturer		 Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Rd
Parsippany NJ 07054-3722
For Additional Information Contact Product Service Department
973-576-0032
Manufacturer 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.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.
Quantity in Commerce 19,884 total
Distribution Nationwide and Foreign.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = IMPLEX CORP.
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