Recall Z-1635-2014— Microline Surgical
Class II · Terminated
Class II FDA medical device recall by Microline Surgical, initiated 2014-04-14, terminated 2015-09-02. It names one FDA 510(k) clearance: K981389. Product: Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.. Reason: Grasper jaw may break when force is applied to the jaw.
- Recalling firm
- Microline Surgical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-14
- Terminated
- 2015-09-02
- Firm location
- Beverly, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.
Reason for recall
Grasper jaw may break when force is applied to the jaw
Data sourced from openFDA. This site is unofficial and independent of the FDA.