# FDA recall Z-1374-2018

> **Tornier, Inc** · Class II · device recall initiated 2018-02-08.

## 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 o

## 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.

## Distribution

US Nationwide Distribution.

## Key facts

- **Recall number:** Z-1374-2018
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-08
- **Report date:** 2018-04-25
- **Termination date:** 2020-08-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1374-2018

## Citation

> AI Analytics. FDA recall Z-1374-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1374-2018. Source: US FDA. Licensed CC0.

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