Z-2600-2016Class II

Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only

Name: Z-2600-2016 Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only
Creator: Integra LifeSciences Corp.
Published: 2016-07-21
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2016-07-21 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a 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 fixation of bone fractures... on 2016-07-21. FDA classified it as Class II and gives the reason as "Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2600-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-21
Posted: 2016-08-19
Terminated: 2017-03-29
Recalling firm: Integra LifeSciences Corporation
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.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Integra sent an Urgent Voluntary Medical Device Recall letter and acknowledgement return response form dated July 21, 2016 to their affected customers. The recall letter identifies the product and lots involved, problem and actions to be taken. All customers are asked to return the completed acknowledgement and return response form by email to [email protected] or fax to 1-609-275-9445. Should any customer has any questions regarding the instructions, they can contact Customer Service at 1-800-654-2873.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2600-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2600-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

Product code HWC

K071639Class IIQwix Positioning ScrewNewdeal Sas / cleared 2007-07-09

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)