Sutures — Class II medical device recall Z-1295-2014
Terminated recall by Teleflex Medical, reported 2014-04-02, distributed nationwide. The products are being recalled because they did not meet minimum needle attachment strength requirements.
| Recall number | Z-1295-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2014-03-11 |
| Classified | 2014-03-25 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2017-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, IE |
| Quantity | 32,271 units |
| Reason classes | potency |
| Lot numbers | 02J0800451 |
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 for recall
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1295-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.