8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Reported: December 3, 2014 Initiated: November 3, 2014 #Z-0435-2015
Product Description
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Reason for Recall
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 509 Total Devices, all affected units
- Distribution
- US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.. Recalled by Intuitive Surgical, Inc.. Units affected: 509 Total Devices, all affected units.
Why was this product recalled? ▼
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2014. Severity: Moderate. Recall number: Z-0435-2015.
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