Recall Z-2600-2016— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2016-07-21, terminated 2017-03-29. It names one FDA 510(k) clearance: K071639. Product: Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.. Reason: Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw"..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-21
- Terminated
- 2017-03-29
- Firm location
- Plainsboro, NJ, 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
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
Reason for recall
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Data sourced from openFDA. This site is unofficial and independent of the FDA.