Recall Z-1234-2024 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes (USA) Products LLC
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
| Date | Mar 1, 2024 (initiated Jan 24, 2024) |
| Status | Open, Classified |
| Reason | Products not sterilized, sterility cannot be confirmed |
| Root cause | Process control |
| Action | DePuy Synthesis issued Urgent Medical Device Recall (Removal Letter ) via email on 1/24/24. In the US, impacted consignees will be notified via mail, sales consultants and email. OUS Affiliates will be notified via email and will inform their impacted customers per their country regulations and procedures. Letter states reason for recall, health risk and action to take: Steps: 1. Examine your inventory immediately to determine if you have the subject products and quarantine them immediately. DO NOT USE THE SUBJECT PRODUCTS. Ref: 2348044 Page 2 of 3 2. Contact your DePuy Synthes Sales Consultan |
| Quantity | 5 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051678 | SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM Synthes (Usa), Sep 21, 2005 |