Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL DORSAL ULNA PLT 234800908 PROXIMAL DORSAL ULNA PLT 234800910 PROXIMAL DORSAL ULNA PLT 234801004 PROXIMAL DORSAL ULNA PLT 234801006 PROXIMAL DORSAL ULNA PLT 234801008 PROXIMAL DORSAL ULNA PLT 234801010 PROXIMAL DORSAL ULNA PLT 10H LT 234701304 PROXIMAL MEDIAL TIBIAL 4. 234701306 PROXIMAL MEDIAL TIBIAL 4. 234701308 PROXIMAL MEDIAL TIBIAL 4. 234701404 PROXIMAL MEDIAL TIBIAL 4. 234701406 PROXIMAL MEDIAL TIBIAL 4. 234701408 PROXIMAL MEDIAL TIBIAL 4. Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: lot no.: 61895477 62274946 61771936 61859733 61895479 62049380 62274957 62274957N 61879883 61771950 61879872 61879874 61918348 61944990 62199039 62312399 62312401 62312402 62312401N 61859738 61944992 62124572 62124572N 61941119 62296602 62233795 62312404 62312404N 61944994 62134044 61771903 62152982 61941121 61944995 62233794 62233796 62296608 61771908 62180987
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer Manufacturing B.V.
- Reason for Recall:
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL DORSAL ULNA PLT 234800908 PROXIMAL DORSAL ULNA PLT 234800910 PROXIMAL DORSAL ULNA PLT 234801004 PROXIMAL DORSAL ULNA PLT 234801006 PROXIMAL DORSAL ULNA PLT 234801008 PROXIMAL DORSAL ULNA PLT 234801010 PROXIMAL DORSAL ULNA PLT 10H LT 234701304 PROXIMAL MEDIAL TIBIAL 4. 234701306 PROXIMAL MEDIAL TIBIAL 4. 234701308 PROXIMAL MEDIAL TIBIAL 4. 234701404 PROXIMAL MEDIAL TIBIAL 4. 234701406 PROXIMAL MEDIAL TIBIAL 4. 234701408 PROXIMAL MEDIAL TIBIAL 4. Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Product Codes/Lot Numbers:
lot no.: 61895477 62274946 61771936 61859733 61895479 62049380 62274957 62274957N 61879883 61771950 61879872 61879874 61918348 61944990 62199039 62312399 62312401 62312402 62312401N 61859738 61944992 62124572 62124572N 61941119 62296602 62233795 62312404 62312404N 61944994 62134044 61771903 62152982 61941121 61944995 62233794 62233796 62296608 61771908 62180987
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1156-2016
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