Class II — Integra LifeSciences Corp.
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw". |
| 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. |
| Quantity | 120 units from multiple lots |
| Distribution | US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA |
| Initiated | 2016-07-21 |
| Classified | 2016-08-19 |
| Terminated | 2017-03-29 |
| Recall number | Z-2600-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corp. (Z-2600-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74855/
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