Recall Z-2145-2012— Smith & Nephew, Inc. Endoscopy Division

Name: FDA recall Z-2145-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-14

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc. Endoscopy Division, initiated 2012-07-14, terminated 2021-03-22. It names one FDA 510(k) clearance: K012314. 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: 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..

Recalling firm: Smith & Nephew, Inc. Endoscopy Division
Classification: Class II
Status: Terminated
Initiated: 2012-07-14
Terminated: 2021-03-22
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K012314 — DYONICS ELECTROBLADE RESECTORSmith & Nephew, Inc.·cleared 2002-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.