The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
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Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
Possible inner labeling and packaged device not matching the outer label on the box.
Possible inner labeling and packaged device not matching the outer label on the box.
Stent length on the label may not match the length of the stent itself.
Class I - Dangerous
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UFRA, size 1 printed on the patient label inside the box.
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Limacorporate S.p.A
Class I - Dangerous
An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Zimmer Biomet
Class I - Dangerous
A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic.
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
St. Jude Medical
Class I - Dangerous
Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.