Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003...
FDA Device Recall #Z-1129-2016 — Class II — January 11, 2016
Recall Summary
| Recall Number | Z-1129-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 11, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Manufacturing B.V. |
| Location | Mercedita, PR |
| Product Type | Devices |
| Quantity | 285 |
Product Description
Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT 118114502 FREE-LOCK TUBE & SCP PLAT 118114503 FREE-LOCK TUBE & SCP PLAT 118115002 FREE-LOCK TUBE & SCP PLAT 118115003 FREE-LOCK TUBE & SCP PLAT Product 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.
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.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
lot no.: 61771007 61827364 61853067 61865449 61870424 61888695 61953208 62230187 61853068 61870425 61953213 62230188 61860667 61895085 61937602 61953221 62230190 62271893 61900049 61900056 61958816 62124265 62124266 62241683 62255907 61778898 61860656 61870426 61853070 61900064 370958 61777470 61834885 61934150 370957 61888707 62271892
Other Recalls from Zimmer Manufacturing B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1676-2016 | Class II | Periarticular plating system, cancellous bone s... | May 4, 2016 |
| Z-1678-2016 | Class II | M/DN Intramedullary Fixation 4.2 mm Diameter Co... | May 4, 2016 |
| Z-1677-2016 | Class II | Zimmer Plates and Screws (ZPS) 4.0 mm Cancell... | May 4, 2016 |
| Z-1684-2016 | Class II | Trilogy self-tapping bone screw Bone screw 4.... | May 4, 2016 |
| Z-1682-2016 | Class II | VersaFx Femoral Fixation System Hex head comp... | May 4, 2016 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.