Smith & Nephew Whipknot Soft Tissue Cinch — Class II medical device recall Z-2745-2016
Terminated recall by Smith & Nephew, Inc., reported 2016-09-14, distributed nationwide. Sterility compromised due to breach in sterile packaging
| Recall number | Z-2745-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Mansfield, MA, United States |
| Recall initiated | 2016-07-19 |
| Classified | 2016-09-07 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2018-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 34,065 units |
| Reason classes | sterility |
| Lot numbers | 50387867, 50388745, 50389780, 50390947, 50392219, 50392401, 50393765, 50394079, 50395093, 50396528, 50396841, 50397925, 50399974, 50400293, 50401451, 50402461, 50402959, 50403376, 50403941, 50405570, 50406358, 50407001, 50407434, 50407950, 50407951, 50408878, 50409545, 50410397, 50411389, 50412044, 50413155, 50414113, 50415145, 50415520, 50415873, 50416326, 50416832, 50417399, 50417668, 50418103 and 188 more |
Product
Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
Reason for recall
Sterility compromised due to breach in sterile packaging
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-2745-2016. 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.