Smith & Nephew 5 — Class II medical device recall Z-2145-2012
Terminated recall by Smith & Nephew, Inc. Endoscopy Division, reported 2012-08-15, distributed nationwide. Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which prod
| Recall number | Z-2145-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc. Endoscopy Division, Andover, MA, United States |
| Recall initiated | 2012-07-14 |
| Classified | 2012-08-03 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2021-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, JP, KR, TR |
| Quantity | 108 units |
| Reason classes | labeling |
| Lot numbers | 655844R, 950143R, 950144R, 950145R, 950146R |
| Model numbers | 7205962 |
Product
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.
Reason for recall
Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
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-2145-2012. 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.