Device product
Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.
Z-1535-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67973
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,380 ea (total)
- Official record key
device-enforcement:Z-1535-2014
Official wording
Reason: The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
Code information: Product Code: 200101-01, Lot # 02F0801290 and Product Code: BP1000V2L, Lot numbers: 02C1003535 & 02F1000711.
Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.
Derived failure modes
-
Unknown
The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.