Overview of recall records associated with Medtronic Sofamor Danek USA, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 66.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Engraving on implants may not match what is listed on the pouch labels.
Engraving on implants may not match what is listed on the pouch labels.
Product is impacted by a thread profile defect due to a manufacturing issue.
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the…
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the…
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the…
This page summarizes recall records in which the official source identifies Medtronic Sofamor Danek USA, 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.
