SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
FDA device recall Z-2049-2014 · posted 2014-07-14 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Sterility of device is compromised due to breach in sterile barrier
- Action taken
- Smith & Nephew issued an Urgent - Product Recall Notification letter dated June 2, 2014 via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and locate all affected product and quarantine them immediately. Complete the Return Certification Form . Contact the Smith & Nephew Returns Group at 800-343-5717 (option 3) or send an email to ProductRecoverv@smith-nephew.com. They will provide customers with instructions for returning their product and receiving a replacement. For questions regardin g this recall call 978-749-1073.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 763 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- Date initiated
- 2014-06-02
- Date posted
- 2014-07-14
- Date terminated
- 2017-09-15
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS (K122059) | Smith & Nephew, Inc. | 2013-03-18 |