Z-2084-2016Class II

K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used...

Name: Z-2084-2016 K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used...
Creator: Integra LifeSciences Corp.
Published: 2016-05-20
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2016-05-20 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws... on 2016-05-20. FDA classified it as Class II and gives the reason as "The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2084-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-20
Posted: 2016-06-28
Terminated: 2016-11-16
Recalling firm: Integra LifeSciences Corporation
Product: K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws
Product code: HXI Passer, Wire, Orthopedic
Reason for recall: The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Integra sent an Urgent Voluntary Medical Device Recall letter dated May 20, 2016, to all affected consignees regarding the recall via traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers who have supplied affected product should forward a copy of the Recall Notice to them. Customers should review their inventory for affected product, complete the form as to whether they have any affected product or not, return the form by email or fax as indicated on the form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 609-936-6822.
Quantity in commerce: 182 units
Distribution: Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA
Product codes and lots: Lot 237830TE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2084-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2084-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28

Product code HXI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)