Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 ...
FDA Device Recall #Z-1161-2016 — Class II — January 11, 2016
Recall Summary
| Recall Number | Z-1161-2016 |
| 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 | 2063 |
Product Description
Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O 620004820 TRILOGY ACET SHELL 48MM O 620004822 TRILOGY ACET SHELL 48MM O 620004823 TRILOGY ACET SHELL 48MM O 620005020 TRILOGY ACET SHELL 50MM O 620005021 TRILOGY ACET SHELL 50MM O 620005022 TRILOGY ACET SHELL 50MM O 620005220 TRILOGY ACET SHELL 52MM O 620005221 TRILOGY ACET SHELL 52MM O 620005222 TRILOGY ACET SHELL 52MM O 620005223 TRILOGY ACET SHELL 52MM O 620005420 TRILOGY ACET SHELL 54MM O 620005421 TRILOGY ACET SHELL 54MM O 620005422 TRILOGY ACET SHELL 54MM O 620005423 TRILOGY ACET SHELL 54MM O 620005620 TRILOGY ACET SHELL 56MM O 620005621 TRILOGY ACET SHELL 56MM O 620005622 TRILOGY ACET SHELL 56MM O 620005623 TRILOGY ACET SHELL 56MM O 620005820 TRILOGY ACET SHELL 58MM O 620005821 TRILOGY ACET SHELL 58MM O 620005822 TRILOGY ACET SHELL 58MM O 620005823 TRILOGY ACET SHELL 58MM O 620006020 TRILOGY ACET SHELL 60MM O 620006022 TRILOGY ACET SHELL 60MM O 620006023 TRILOGY ACET SHELL 60MM O 620006021 TRILOGY ACET SHELL 60MM OD SOLID 620006220 TRILOGY ACET SHELL 62MM O 620006221 TRILOGY ACET SHELL 62MM O 620006222 TRILOGY ACET SHELL 62MM O 620006420 TRILOGY ACET SHELL 64MM O 620006422 TRILOGY ACET SHELL 64MM O 620006620 TRILOGY ACET SHELL 66MM O For use in total hip arthroplasty
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.: 61564135 62126347 61564135R 62251853 62298252 62298252N 61873598 62156174 61846474 61867232 61867233 61947557 62352860 62195511 61580837 61638704 61808993 61837768 62159817 62209893 62339997 62352861 61655829 61665436 61665438 61809036 61864075 61873615 61880354 61943340 61957101 61967998 62076914 62076915 62136636 62154300 62154301 62189392 62240665 62251935 62352862 61817455 61638709 61638710 61864066 61926574 62096972 62240233 62291912 62291912N 61642324 61642325 61627447 61642348 61642355 61867247 61873610 61880350 61880351 61880353 61921684 61923932 61923933 61930395 61953121 61964705 61999747 62188279 62189398 62227006 62234425 62268598 62268603 62285249 62324089 62328956 62285249N 62324089N 62328956N 62060654 62346538 61642326 62251915 61612738 61642361 61642362 61665449 61839045 61840613 61873620 61878443 61884427 61957145 61976123 62060665 62079960 62140524 62165182 62204505 62227010 62234432 62238066 62298271 62309166 62340010 62340011 62340012 62345687 62345690 62309166N 61630550 61803767 61633898 61640799 62105165 62105166 62152061 62152062 62334189 62340015 62346541 62334189N 61840614 61928503 62154514 62203160 61271342 61548278 61661050 61839048 61880361 61884428 61957158 61976135 61976136 62073495 62113213 62143832 62160167 62162433 62178685 62204506 62208743 62218101 62255990 62281822 62340018 62340019 62346543 62346544 62219404 61640807 61941685 62136643 62177334 62240689 62309157 62358865 62363071 62309157N 61813945 61813948 61885848 61873618 61986615 62147323 62154539 62154541 62174599 62188275 62317180 62354677 62354678 62354679 62358863 62358864 62317180N 61921683 62222743 61612718 61837769 61837770 61837771 61964699 62021100 62021101 62140518 62140519 62352868 62358867 62359986 61611815 62079956 62255913 62352869 61532303 61611319 61611320 61612757 61661038 61682017 61839047 61869699 61873623 61976141 61987187 61987188 62060663 62140112 62154304 62162429 62178689 62181416 62193405 62352870 62352871 62358875 62358876 61809012 61952422 61532286 61612724 61635715 61813943 61980778 62006521 62010596 62010597 62154296 62262707 62303486 62340027 62354687 62358870 61825831 62170554 62177331 62188261 62238070 62240206 62246351 62354689 62354690 62358874 61923872 62176904 62358873 61638719 61883391 62170040 62255909 62006522 62006522N 61642367 61642368 61642369 61642370 61642371 61837775 61837776 61883395 61976148 61976149 62255923 61642368R 61612732 61642202 62218099 62301417 61642372 62183119 62287319 370608
Other Recalls from Zimmer Manufacturing B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1677-2016 | Class II | Zimmer Plates and Screws (ZPS) 4.0 mm Cancell... | May 4, 2016 |
| Z-1678-2016 | Class II | M/DN Intramedullary Fixation 4.2 mm Diameter Co... | May 4, 2016 |
| Z-1684-2016 | Class II | Trilogy self-tapping bone screw Bone screw 4.... | May 4, 2016 |
| Z-1676-2016 | Class II | Periarticular plating system, cancellous bone s... | May 4, 2016 |
| Z-1681-2016 | Class II | ITST intertrochanteric/subtrochanteric fixati... | 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.