Certain Conical Abutment Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
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Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
DAL-RO Threaded Female Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
METS SMILES Total Knee Replacement
Stanmore Implants Worldwide
Class I - Dangerous
The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
Straumann Manufacturing
Class I - Dangerous
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Certain Provide Abutment Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Cover Screw, Headless Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Certain Preformance Post Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
Stryker Howmedica Osteonics
Class I - Dangerous
It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
Incorrect drill protocol in the Instructions for Use (IFU)
Class I - Dangerous
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Zimmer Biomet Spine
Class I - Dangerous
Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.