Zimmer GmbH
Zimmer GmbH holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2023, with 99 FDA device recalls on record.
Top product codes for Zimmer GmbH
FDA recalls by Zimmer GmbH
10 most recent of 99- Z-3133-2024 — Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
- Z-3132-2024 — Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
- Z-1793-2021 — Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11
- Z-1792-2021 — Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
- Z-2762-2019 — Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
- Z-1455-2019 — CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
- Z-1457-2019 — CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
- Z-1483-2019 — Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635
- Z-1414-2019 — Drill Sys2.7, 2x103mm, AO, Item Number 502015107
- Z-1431-2019 — Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Zimmer GmbH
- K211047 — CoCr Head
- K200814 — Affixus(R) Natural Nail(R) System Humeral Nail
- K200112 — Zimmer Hip Joint Replacement
- K193099 — Anatomical Shoulder System
- K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
- K193030 — Avenir Muller Stem, Avenir Cemented Hip Stem
- K192236 — Fitmore Hip Stem
- K192312 — Zimmer Natural Nail System Cephalomedullary Nails
- K192416 — BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
- K192217 — NCB Plating System Distal Femur and Proximal Tibia
- K192021 — NCB Polyaxial Locking Plate System
- K191781 — Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
- K181827 — Affixus Natural Nail System Humeral Nail
- K171858 — Sidus Stem-Free Shoulder
- K170711 — ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System
- K170072 — Fitmore® Hip Stem
- K161620 — Anatomical Shoulder Domelock Dome centric
- K161192 — Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
- K160085 — Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
- K142403 — Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
- K131884 — AVENIR CEMENTED HIP STEM
- K130899 — BIOLOX DELTA CERAMIC FEMORAL HEADS
- K123392 — AVENIR MULLER STEM
- K120715 — ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
- K120772 — NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
- K113556 — WAGNER CONE PROSTHESIS SYSTEM
- K113718 — NCB STRAIGHT NARROW SHAFT PLATES
- K110836 — CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
- K103404 — ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
- K091003 — ZIMMER MMC CUP
- K091973 — METASUL TAPER LINERS, METASUL FEMORAL HEADS
- K091566 — ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
- K081759 — NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V
- K073567 — BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
- K071723 — ZIMMER POROLOCK MIS STEM
- K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
- K062029 — ANATOMICAL SHOULDER FRACTURE SYSTEM
- K061211 — NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
- K053536 — DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
- K053274 — ANATOMICAL SHOULDER INVERSE/REVERSE
- K051623 — ANATOMICAL SHOULDER KEELED GLENOID
- K043270 — SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
- K042695 — NCB PLATING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.