Reported Aug 31, 2016 · Terminated
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only
- Product UsageThe QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction
- Lot codes and dates
- Model Numbers
121530S121535S121540S121545S121550S121555S121560S121565S121570S121575S121580S121740S121745S121750S121755S121760S121765S121770S121775S121780S121785S121790S121795S121800S121805S121810S121815S and 121820S
- Model Numbers
- Amount recalled
- 120 units from multiple lots
Where it was sold
Why it was recalled
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Integra LifeSciences Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.