Onkos Surgical ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED recall — FDA Z-2425-2025
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Overview of recall records associated with Onkos Surgical, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 12.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
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…
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
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…
This page summarizes recall records in which the official source identifies Onkos Surgical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.