Medtronic Sofamor Danek USA Recalls

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: Engraving on implants may not match what is listed on the pouch labels.

Hazard: Engraving on implants may not match what is listed on the pouch labels.

Hazard: Product is impacted by a thread profile defect due to a manufacturing issue.

Hazard: 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.

Hazard: 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.

Hazard: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Hazard: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Hazard: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Hazard: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Hazard: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Hazard: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Hazard: 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 required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

Hazard: 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 required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

Hazard: 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 required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

Hazard: Nonconforming product; length of the product measured shorter than the labeled length.

Hazard: The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

Hazard: This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.

Hazard: Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.

Hazard: The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.

Hazard: Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.

Hazard: Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.

Hazard: The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.

Hazard: Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.

Hazard: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

Hazard: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.