Recall Z-1560-2014
Teleflex Medical · initiated March 11, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product Code X-4981M4 - Lot 02J0800451
Reason for recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
FDA-determined cause: Employee error
Action taken
Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.
Details
- Recall number
- Z-1560-2014
- Initiated
- March 11, 2014
- Posted by FDA
- May 7, 2014
- Terminated
- August 14, 2017
- Product code
- GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Quantity
- 32,271 ea.
- Distribution
- Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
- Recalling firm
- Teleflex Medical, Durham, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1555-2014 Class II | Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1556-2014 Class II | Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1557-2014 Class II | Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1558-2014 Class II | Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1559-2014 Class II | Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1561-2014 Class II | Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |