Recall Z-1374-2018 ยท NWJ Suture, Recombinant Technology
Tornier, Inc
Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDL
| Date | Feb 8, 2018 |
| Status | Terminated |
| Reason | Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Wright, sent an "Urgent Field Safety Notice" letter by email on 02/08/2018. The firm followed up with a letter on April 02, 2018 disseminated by FedEx Priority mail to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following actions: " Cease using the affected devices immediately. " Medical facilities are to determine if any of the recalled implants are on hand, and return affected implants immediately to Wright Medical. "Review the notice and complete the Acknowledgement Section Attachment C to signify that |
| Quantity | 32253 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130422 | PHANTOM FIBER BIOFIBER SUTURE Tornier, Inc., Apr 4, 2013 |