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TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB S...

FDA Device Recall #Z-1951-2016 — Class II — April 15, 2016

Recall Summary

Recall Number Z-1951-2016
Classification Class II — Moderate risk
Date Initiated April 15, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer Trabecular Metal Technology, Inc.
Location Parsippany, NJ
Product Type Devices
Quantity 19,884 total

Product Description

TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM - 00588604414 TM CR TIB SZ 4 C-H, 17MM - 00588604417, 00588604510 TM CR TIB SZ 5 C-H, 12MM - 00588604512 TM CR TIB SZ 5 C-H, 14MM - 00588604514 TM CR TIB SZ 5 C-H, 17MM - 00588604517, 00588604610 TM CR TIB SZ 6 C-H, 12MM 00588604612 TM CR TIB SZ 6 C-H, 14 MM 00588604614 TM CR TIB SZ 6 C-H, 17 MM 00588604617 TM CR TIB SZ 7 C-H, 10MM - 00588604710 TM CR TIB SZ 7 C-H, 12MM - 00588604712 TM CR TIB SZ 7 C-H, 14MM - 00588604714 TM CR TIB SZ 7 C-H, 17MM - 00588604717 TM CR TIB SZ 8 C-H, 10MM - 00588604810 TM CR TIB SZ 8 C-H, 12MM - 00588604812 TM CR TIB SZ 8 C-H, 14MM - 00588604814

Reason for Recall

Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

Distribution Pattern

Nationwide and Foreign.

Lot / Code Information

00588604310 TM CR TIB SZ 3 C-H, 10MM 61746701 61746701 61746702 61752725 61759780 61769546 61776838 61776839 61770816 61785348 61797187 61792632 61792633 61797183 61797182 61797181 61797184 61820708 61820710 61820709 61833813 61839384 61833812 61844335 61844336 00588604312 TM CR TIB SZ 3 C-H, 12MM 61746699 61759781 61776842 61770815 61785349 61797192 61797191 61808975 61833814 61851747 00588604314 TM CR TIB SZ 3 C-H, 14MM 61740710 61785350 61797194 61808984 00588604317 TM CR TIB SZ 3 C-H, 17MM 61746678 61759782 61785351 00588604410 TM CR TIB SZ 4 C-H, 10MM 61733408 61752758 61752759 61759791 61759792 61776830 61770821 61770822 61792647 61792649 61792648 61803945 61803944 61803946 61809003 61809004 61820711 61828074 61828075 61833817 61833818 61839368 61839376 61839390 61857205 61857207 00588604412 TM CR TIB SZ 4 C-H, 12MM 61759793 61776831 61770818 61792651 61803950 61803951 61803952 61809002 61828076 61833821 61833822 61844350 61857204 00588604414 TM CR TIB SZ 4 C-H, 14MM 61733409 61769569 61792653 61803953 61808998 61839386 61857217 00588604417 TM CR TIB SZ 4 C-H, 17MM 61759794 61792654 61803954 00588604510 61746703 61746726 61769547 61770833 61770824 61769548 61780780 61785361 61785362 61780778 61780779 61797201 61792658 61803927 61809014 61809013 61814245 61797202 61814246 61828082 61828083 61828084 61833824 61833825 61839378 61844352 61851749 61857222 61857228 00588604512 TM CR TIB SZ 5 C-H, 12MM 61746719 61769550 61770831 61769551 61785363 61780782 61792659 61797204 61814247 61828085 61833829 61833826 61839380 61851752 00588604514 TM CR TIB SZ 5 C-H, 14MM 61770827 61785364 61797205 61792660 61828081 61844344 61857223 00588604517 TM CR TIB SZ 5 C-H, 17MM 61746709 61770825 61785365 00588604612 TM CR TIB SZ 6 C-H, 12MM 61733401 61746705 61759774 61770838 61780791 61785379 61792665 61809052 61809053 61828087 61851757 00588604614 TM CR TIB SZ 6 C-H, 14MM 61746707 61733402 61759775 61792666 61828088 61851761 00588604617 TM CR TIB SZ 6 C-H, 17MM 61759776 61785378 61809046 00588604710 TM CR TIB SZ 7 C-H, 10MM 61746730 61739891 61746729 61776818 61776819 61770845 61770846 61792672 61797212 61809055 61814252 61828089 61833834 61833832 61851764 61851765 00588604712 TM CR TIB SZ 7 C-H, 12MM 61739889 61746728 61770844 61776821 61797217 61792675 61814251 61828090 61833833 61844354 61851762 00588604714 TM CR TIB SZ 7 C-H, 14MM 61785384 61792676 61809056 00588604717 TM CR TIB SZ 7 C-H, 17MM 61776822 61785385 61809057 00588604810 TM CR TIB SZ 8 C-H, 10MM 61733390 61776826 61792688 61803937 61844355 00588604812 TM CR TIB SZ 8 C-H, 12MM 61769567 61776827 61792689 00588604814 TM CR TIB SZ 8 C-H, 14MM 61733392

Other Recalls from Zimmer Trabecular Metal Technology, Inc.

Recall # Classification Product Date
Z-1006-2019 Class II NexGenTrabecular Metal Tibial Half Block Augmen... Feb 1, 2019
Z-1005-2019 Class II NexGenTrabecular Metal Tibial Half Block Augmen... Feb 1, 2019
Z-1892-2017 Class III The TM Ardis Interbody System implant is a conv... Jul 7, 2016
Z-1952-2016 Class II TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM L... Apr 15, 2016
Z-1953-2016 Class II TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO... Apr 15, 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.

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