FDA Device recall Z-1560-2014
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for…
- FDA Device
- Class II
- terminated
- Published 2014-05-14
On 2014-05-14 the FDA classified a Class II recall of Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for… by Teleflex Medical, citing product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1560-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-11 |
| Published | 2014-05-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | AL, CA, FL, GA, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI, WV |
Product
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. 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
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Identifiers
| code_info | Product Code X-4981M4 - Lot 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-1560-2014%22
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