CLASS II Device recall · Reported 2 Apr 2014 · FDA Enforcement Report
Sutures, Non-absorbable, Steel, Monofilament recalled
Teleflex Medical is recalling Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, distributed nationwide in the US. The recall was initiated on 11 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1295-2014
- FDA event ID
- 67733
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2014
- FDA classified
- 25 Mar 2014
- Reported
- 2 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 11 Mar 2014 | Recall initiated by company | |
| 25 Mar 2014 | Classified by FDA | +14 days |
| 2 Apr 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or Ushaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Where it was distributed
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Questions about this recall
Why was it recalled?
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Which lots are affected?
Product Code: X-4981M4, Lot number: 02J0800451
Where was it sold?
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 67733This product is part of a recall event; the main page for the event is Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile recalled | Teleflex Medical | Other | Nationwide | |
| CLASS II | Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile recalled | Teleflex Medical | Other | Nationwide | |
| CLASS II | Suture, Non-absorbable, Synthetic, Polyamide, Sterile recalled | Teleflex Medical | Other | Nationwide | |
| CLASS II | Sutures, Non-absorbable, Silk, Sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS II | Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile recalled | Teleflex Medical | Other | Nationwide |
More recalls from Teleflex Medical
All 235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS II | Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |