Recall Z-3097-2024 ยท GDW Staple, Implantable
Smith & Nephew Inc.
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
| Date | Sep 10, 2024 (initiated Aug 12, 2024) |
| Status | Open, Classified |
| Reason | Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
| Root cause | Packaging |
| Action | Smith & Nephew issued Urgent Medical Device Recall Notice R-2024-06 on 8/12/24. Letter states reason for recall, health risk and action to take: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customer s account number and name in Section A. 2. If you have no product to return: a. Pl |
| Quantity | 2961 units (OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Swi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131637 | ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) Rotation Medical, Inc., Jul 12, 2013 |