Class I - Dangerous
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Onkos Surgical
16 recalls • • Categories: Implants & Prosthetics, Other Medical Devices, Diagnostic Equipment
Class I - Dangerous
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class I - Dangerous
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class I - Dangerous
Required inspections were not performed on finished product prior to release and distribution.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Class I - Dangerous
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Class I - Dangerous
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Class I - Dangerous
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Class I - Dangerous
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Class I - Dangerous
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Class I - Dangerous
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Class I - Dangerous
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm