Z-1374-2018Class II

Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE...

Name: Z-1374-2018 Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE...
Creator: Tornier, Inc
Published: 2018-02-08
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2018-02-08 / Terminated / root cause: manufacturing process

FDA source

Tornier, Inc began a recall of 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... on 2018-02-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1374-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-08
Posted: 2018-04-13
Terminated: 2020-08-07
Recalling firm: TORNIER Inc.
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.
Product code: NWJ Suture, Recombinant Technology
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.
Root cause tag: manufacturing process
FDA 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 your facility has been informed of this Field Safety Notice (Recall). " Return the completed Acknowledgement to Wright Medical via email to: [email protected] 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: [email protected] or Phone: 952.683.7482.
Quantity in commerce: 32253 units
Distribution: US Nationwide Distribution.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1374-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1374-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-13

Product code NWJ

K130422Class IIPhantom Fiber Biofiber SutureTornier, Inc. / cleared 2013-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)