Class 2 Device Recall Phantom Fiber Biofiber Sutures

• Date Initiated by Firm: February 08, 2018
• Create Date: April 13, 2018
• Recall Status: Terminated on August 07, 2020
• Recall Number: Z-1374-2018
• Recall Event ID: 79373
• 510(K)Number: K130422
• Product Classification: Suture, recombinant technology - Product Code NWJ
• Product: 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 NEEDLED; SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE; SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED; SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET; SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED; SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET; SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED; SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET; SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET; ; Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
• Code Information: All lots
• Recalling Firm/ Manufacturer: Tornier, Inc; 10801 Nesbitt Ave S; Bloomington MN 55437-3109
• For Additional Information Contact: 952-683-7482
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 your facility has been informed of this Field Safety Notice (Recall). " Return the completed Acknowledgement to Wright Medical via email to: FieldAction@wright.com within five (5) working days of this notice. "Contact customer service at 1-888-494-7950 to facilitate any product returns. For any inquiries regarding the Phantom Fiber Field Safety Notice (Recall) contact: Wright Medical Quality Systems Manager by Email: FieldAction@wright.com or Phone: 952.683.7482.
• Quantity in Commerce: 32253 units
• Distribution: US Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NWJ and Original Applicant = TORNIER, INC.