Recall Z-1197-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 810508345 NAIL TIB DYN 08 X 34.5 810508360 NAIL TIB DYN 08 X 36.0 810508375 NAIL TIB DYN 08 X 37.5 810508390 NAIL TIB DYN 08 X 3
| Date | Mar 14, 2018 (initiated Feb 6, 2018) |
| Status | Terminated |
| Reason | The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system. |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall letter dated February 06, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your Zimmer Biomet sales representative will remove it from your facility. 3. Complete the Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. DISTRIBUTOR: 1. Review this notification and notify affected team members of the contents.2. Qu |
| Quantity | Not known |
| Distribution | Worldwide and US of Indiana and country of the Republic of Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972183 | DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL Ace Medical Co., Aug 26, 1997 |