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.

26–41 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Cable-Ready Short and Long GTR Implants

    Zimmer Biomet is recalling Cable-Ready Short and Long GTR implants because non-highly polished units may adhere to the LDPE bag.

    Product
    CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
    Category
    Distribution
    0 states
  • 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
    Category
    Distribution
    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls NCB Proximal Lateral Tibia Implants

    Zimmer Biomet is recalling NCB Proximal Lateral Tibia implants because non-highly polished devices may adhere to the packaging bag.

    Product
    NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313
    Category
    Distribution
    0 states
  • 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls BF Humeral Stems Due to Packaging Adhesion

    Zimmer Biomet is recalling BF Humeral Stems because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Cephalomedullary Nails Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million cephalomedullary nails because non-highly polished implants may adhere to the packaging bags.

    Product
    Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 47249318114 47249318209 47249318210 47249318211 47249318213 47249318214 47249318309 47249318310…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Prox Lat Humeral Lock Plates Due to Packaging Adhesion

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

    Product
    PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212
    Category
    Distribution
    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…
    Category
    Distribution
    0 states
  • 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
    Category
    Distribution
    0 states
  • 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
    Category
    Distribution
    0 states
  • 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
    Category
    Distribution
    0 states
  • 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…
    Category
    Distribution
    0 states
  • 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-11-13

    Zimmer Biomet Recalls Periarticular Femur Plates Due to Packaging Adhesion

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

    Product
    PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 00234700208 00234700210 00234700212 00234700214 00234700216 00234700218 00234703104 00234703106 00234703108 00234703204…
    Category
    Distribution
    0 states