Zimmer Recalls

Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Hazard: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Hazard: Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .

Hazard: A potential commingle that could result in the product in the package not matching the product on the outer label.

Hazard: A potential commingle that could result in the product in the package not matching the product on the outer label.

Hazard: Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.

Hazard: the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.

Hazard: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.

Hazard: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.

Hazard: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.

Hazard: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.

Hazard: Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.

Hazard: In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.

Hazard: The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.

Hazard: The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.

Hazard: Complaints that the ratchet teeth of the tube are not latching onto the rod.

Hazard: Complaints that the ratchet teeth of the tube are not latching onto the rod.

Hazard: In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.

Hazard: It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat

Hazard: Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.

Hazard: A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.

Hazard: Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.

Hazard: Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv¿ femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biological response and subsequent revision

Hazard: Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.

Hazard: The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing.

Hazard: The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery

Hazard: Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.

Hazard: Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications.

Hazard: An increase in complaints of loosening and radiolucent lines.

Hazard: PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.