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 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 002347
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls NCB Periprosthetic Proximal Femoral Plates
Zimmer Biomet is recalling NCB Periprosthetic Proximal Femoral Plates because non-highly polished implants may adhere to the packaging bag.
Product
NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 020226
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls Various Fixation Systems and Accessories
Zimmer Biomet is recalling various fixation systems and accessories because non-highly polished implants may adhere to the LDPE bag.
Product
Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 0011810
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls Distal Lateral Femoral Locking Plates
Zimmer Biomet is recalling 5,459,583 sterile distal lateral femoral locking plates because non-highly polished implants may adhere to the packaging bag.
Product
DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222
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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
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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 0043
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls Ceramic Femoral Heads Due to Packaging Adhesion
Zimmer Biomet is recalling 5.4 million ceramic femoral heads because non-highly polished implants may adhere to the LDPE bag packaging.
Product
Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
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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
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls Various Fixation Systems and Accessories
Zimmer Biomet is recalling various fixation systems and accessories because non-highly polished implants may adhere to the LDPE bag.
Product
Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014 0022400
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls NCB-PH Plates Due to Packaging Adhesion
Zimmer Biomet is recalling NCB-PH plates because non-highly polished implants may adhere to the LDPE bag packaging.
Product
NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107
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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 47249
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls NCB Straight Narrow Plates Due to Packaging Adhesion
Zimmer Biomet is recalling NCB Straight Narrow Plates because non-highly polished implants may adhere to the LDPE bag packaging.
Product
NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018
Category
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls Femorotibial and Femoral Nails Due to Packaging Adhesion
Zimmer Biomet is recalling femorotibial and femoral nails because non-highly polished implants may adhere to the previous LDPE packaging bag.
Product
FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165
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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
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls Periarticular Locking Elbow Plates Due to Packaging Adhesion
Zimmer Biomet is recalling 5.4 million periarticular locking elbow plates because non-highly polished implants may adhere to the packaging bag.
Product
Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47235800607 47235800609 47235800611 47235800615 47235800619 47235800705 47235800711 47235800715 47235800803 47235800805 47235
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0 states
ModerateFDA (Devices)··2019-11-13
Zimmer Biomet Recalls Sidus Stem-Free Shoulder Humeral Head Implants
Zimmer Biomet is recalling Sidus Stem-Free Shoulder Humeral Head implants because non-highly polished units may adhere to the LDPE bag.
Product
Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525
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0 states