Complete FDA and NHTSA recall records dated in April 2018.
These records include useful source details for the selected month.
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to…
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized…
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes…
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to…
The SIGMA HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post…
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Product reportedly shutting down during use.
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Affected lots may have exceeded its microbial limits.
Increased amount of residual blood present on the top of stopper well after venipuncture
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
