Recall Z-2610-2014— Ethicon Endo-Surgery Inc
Class II · Terminated
Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2014-08-12, terminated 2015-07-10. FDA's recall record names no specific 510(k) clearance for this event. Product: PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.. Reason: The device may have a non-conforming component that may cause the device to fire an unformed staple..
- Recalling firm
- Ethicon Endo-Surgery Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-12
- Terminated
- 2015-07-10
- Firm location
- Blue Ash, OH, United States
Product description
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.
Reason for recall
The device may have a non-conforming component that may cause the device to fire an unformed staple.
Data sourced from openFDA. This site is unofficial and independent of the FDA.