FDA Device recall Z-1295-2014
Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixatio…
- FDA Device
- Class II
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class II recall of Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixatio… by Teleflex Medical, citing the products are being recalled because they did not meet minimum needle attachment strength requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1295-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-11 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
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.
Reason
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Identifiers
| code_info | Product Code: X-4981M4, Lot number: 02J0800451 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1295-2014%22
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