FDA Device recall Z-1374-2018
Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.… by Tornier, citing 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 wh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1374-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-08 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tornier |
| Distribution | US |
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.
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1374-2018%22
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