ðĨ Medical Devices âĒ 4,589 recalls
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Orthosoft, Inc.
The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.
Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Howmedica Osteonics
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
Howmedica Osteonics
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
DePuy Orthopaedics
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
DePuy Orthopaedics
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Straumann USA
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
There have been reports of stent migration.
Medtronic Neuromodulation
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.