FDA (Devices) recall action 65413

Zimmer, Inc. recalled 47 products on 2013-08-28

The FDA (Devices) publishes a recall like this one as 47 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 47 pages.

Products: 47
Announced: 2013-08-28
Critical: 0
Units: 9,040,685

Why these products were recalled

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

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.

26–47 of 47

SevereFDA (Devices)··2013-08-28
Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile; 0059
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HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Recall for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile; 00597602014 Articular Surface AC ART SURF 12/PUR 14, Rx, Sterile; 00597602017 Articular Surface AC ART SURF 12/PUR 17, Rx, Sterile; 0059
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0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx
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0 states
HighFDA (Devices)··2013-08-28
Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.
Product
00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Ster
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0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; 00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile; 00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12, Rx, Sterile; 00597004114 Articular Surface CR ART SURF 56/ST
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0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
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0 states
HighFDA (Devices)··2013-08-28
Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arth
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HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR knee implant components because surgeons are using them in unapproved combinations. The recall covers 192,355 devices distributed in the US and Japan.
Product
90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; 90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
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0 states
HighFDA (Devices)··2013-08-28
Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations, specifically mixing micro and standard parts.
Product
90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/ST
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.
Product
90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM,
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.
Product
00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE Y
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0 states
HighFDA (Devices)··2013-08-28
Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femu
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.
Product
00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx,
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597203114 Articular Surface CR ART SURF 34/STRIPE
Category
Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Recall Due to Unapproved Component Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.
Product
65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.
Product
00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRI
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
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Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations. The issue persists despite a previous 2012 recall.
Product
00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Category
Distribution
0 states
HighFDA (Devices)··2013-08-28
Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; 00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile; 00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14, Rx, Sterile; 00597604117 Articular Surface AC ART SURF 56/STRI
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0 states