The Recall Desk

FDA (Devices) recall action 83962

Zimmer Biomet, Inc. recalled 41 products on 2019-11-13

The FDA (Devices) publishes a recall like this one as 41 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 41 pages.

Products
41
Announced
2019-11-13
Critical
0
Units
223,842,903

Why these products were recalled

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

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.

1–25 of 41

  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Metasul Taper Liners Due to Packaging Adhesion

    Zimmer Biomet is recalling Metasul Taper Liners because non-highly polished implants may adhere to the LDPE bag. The recall covers devices manufactured prior to January 2014.

    Product
    Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732 00877000832 00877000936 00877001036 00877001140 00877001240 00877001340 00877001440 00877001540 00877001640 00877001740 00877001840 00877001940 00877002040 00877002140 00877002240
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Temporary Surgical Devices Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million temporary surgical devices because non-highly polished implants may adhere to the packaging bag.

    Product
    Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 4722580
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Hip Joint Replacement Systems Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million hip joint replacement systems because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 00151505644 00151505848 00151506048 00151506248 00151506448 00151506648 00400500060 00401000038 00401000040 00401000041 0040100004
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Tibia Lock Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling Prox Lat Tib Lock Plates and Dist Med Tib Lock Plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506 47235700508 47235700510 47235700512 47235700514 4723570
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  • HighFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Custom Medical Devices Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million custom medical devices because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Connection Screws for NCB Plates

    Zimmer Biomet is recalling 5,459,583 Connection Screws for NCB Plates because non-highly polished implants may adhere to the LDPE bag.

    Product
    Connection Screw for NCB Plate, Item No. 0202266002
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    0 states
  • HighFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Periarticular Shoulder Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling 5,459,583 periarticular shoulder plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800
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    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Trabecular Metal Reverse Shoulder System Implants

    Zimmer Biomet is recalling Trabecular Metal Reverse Shoulder System implants because non-highly polished components may adhere to the packaging bag.

    Product
    Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 0043421
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    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls CLS Brevius Stem Kinectiv Hip Prostheses

    Zimmer Biomet is recalling CLS Brevius Stem Kinectiv hip prostheses because non-highly polished implants may adhere to the packaging bag.

    Product
    CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion

    Zimmer Biomet is recalling various knee systems because non-highly polished implants may adhere to the LDPE bag.

    Product
    Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531 3
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Cable Buttons for Polyaxial Locking Plates

    Zimmer Biomet is recalling cable buttons for NCB Polyaxial Locking Plates because non-highly polished implants may adhere to the packaging bag.

    Product
    cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
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    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Peri Dist Volar/Dorsal T/Dorsal Delta Radial Implants

    Zimmer Biomet is recalling specific wrist implants because non-highly polished devices may adhere to the packaging bag.

    Product
    PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 00234801412 00234802102 00234802104 00234802106 00234802108 00234802110 0
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion

    Zimmer Biomet is recalling various knee systems because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Coorad Morrey Total Elbow Implants

    Zimmer Biomet is recalling Coorad Morrey Total Elbow implants because non-highly polished components may adhere to the packaging bag.

    Product
    Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510822 32855510843 32855510844
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Limb Salvage Arthroplasty Devices Due to Packaging Issue

    Zimmer Biomet is recalling 5,459,583 limb salvage arthroplasty devices because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Fitmore Hip Stems Due to Packaging Adhesion

    Zimmer Biomet is recalling Fitmore Hip Stems because non-highly polished implants may adhere to the LDPE bag used in previous packaging configurations.

    Product
    Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 0100551114 0100551201 0100551202 0100551203 0100551204 0100551205 01005
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    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Tibial Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million tibial plates because non-highly polished implants may adhere to the packaging bag.

    Product
    Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 00234700414 00234700416 00234700502 00234700504 00234700506 00234700508 00234
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls ZPLP Fibular Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling ZPLP Fibular Plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 002
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Metasul Femoral Heads Due to Packaging Adhesion

    Zimmer Biomet is recalling Metasul Femoral Heads because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
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    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Various Surgical Screws and Reamers

    Zimmer Biomet is recalling various surgical screws and reamers because non-highly polished implants may adhere to the LDPE bag.

    Product
    Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Universal Locking Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million Universal Locking Plates because non-highly polished implants may adhere to the packaging bag.

    Product
    Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Periarticular Elbow and Humeral Plates

    Zimmer Biomet is recalling specific periarticular plates because non-highly polished implants may adhere to the packaging bag.

    Product
    Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 00234800604 00234800606 00234800608 00234800610 00234800612 00234800614 00234800712 00234800714 00234800716 00234800902 002348
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Ankle Implants Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million ankle implants because non-highly polished devices may adhere to the packaging bag.

    Product
    TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
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  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Spinal Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling specific spinal plates because non-highly polished implants may adhere to the packaging bag.

    Product
    SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210
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