Recall Z-3085-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 400 mm, Item Number: 814409400
| Date | Sep 13, 2018 (initiated Jul 17, 2018) |
| Status | Terminated |
| Reason | The set screw is not able to advance or reverse from the original position in the nail. |
| Root cause | Under Investigation by firm |
| Action | On 7/17/18, Urgent Medical Device Recall letters were sent to Risk Managers and Distributors. The letters instructed customers to do the following: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimme |
| Quantity | 5947 total |
| Distribution | The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign coun |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100238 | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM DePuy Orthopaedics, Inc., May 11, 2010 |