Recall Z-1376-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Wright Medical Technology, Inc.
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
| Date | Mar 14, 2018 |
| Status | Terminated |
| Reason | Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. |
| Root cause | Under Investigation by firm |
| Action | Firm initiated the recall on 03/14/2018 by email communication to distribution centers and distributor consignees, along with a field note to all sales representatives. The firm requested return of the product. |
| Quantity | 50 units |
| Distribution | US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090857 | VALOR ANKLE FUSION NAIL SYSTEM Wrightmedicaltechnologyinc, Jul 14, 2009 |