Reported Apr 25, 2018 · Terminated
Fornier Phantom Fiber(TM) Sutures
Tornier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109
Is this the product you have?
Fornier Phantom Fiber(TM) Sutures
12 of 12 products
| Model / number | Product as published |
|---|---|
4.5 | SMB000425 |
5.5 | MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 |
4.5 | MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 |
5.5 | MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 |
1PK | MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 |
10 | BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 |
10 | PK PHANTOM FIBER SZ 2 WHITE SMSB0112N |
1PK | PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 |
10 | BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 |
10 | PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N |
1PK | PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 |
10 | PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 |
- Lot codes and dates
- All lots
- Amount recalled
- 32253 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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