FDA Device recall Z-2600-2016
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 fixati…
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of 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 fixati… by Integra Lifesciences, citing labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2600-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-21 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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".
Identifiers
| code_info | Model Numbers: 121530S, 121535S, 121540S, 121545S, 121550S, 121555S, 121560S, 121565S, 121570S, 121575S, 121580S, 12174…Model Numbers: 121530S, 121535S, 121540S, 121545S, 121550S, 121555S, 121560S, 121565S, 121570S, 121575S, 121580S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S and 121820S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2600-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.