Dekna-lok — Class II medical device recall Z-1535-2014
Terminated recall by Teleflex Medical, reported 2014-05-07, distributed nationwide. The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
| Recall number | Z-1535-2014 |
|---|---|
| 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 | 2014-05-01 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2016-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | IE, SG |
| Quantity | 7,380 units |
| Reason classes | potency |
| Lot numbers | 02C1003535, 02F0801290, 02F1000711 |
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.
Reason for recall
The product did not meet minimum and/or average minimum Teleflex resorption 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-1535-2014. 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.