Z-1146-2015Class II

Set Screw 5.5 mm Rod - Model #7703-1600

Name: Z-1146-2015 Set Screw 5.5 mm Rod - Model #7703-1600
Creator: Biomet Spine, LLC
Published: 2012-11-30
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2012-11-30 / Terminated / root cause: manufacturing process

FDA source

Biomet Spine, LLC began a recall of Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or... on 2012-11-30. FDA classified it as Class II and gives the reason as "Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification". 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-1146-2015
Classification: Class II
Status: Terminated
Initiated: 2012-11-30
Posted: 2015-02-24
Terminated: 2015-05-22
Recalling firm: Highridge Medical, LLC
Product: Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Biomet Spine LLC (formerly Lanx) sent an Urgent Recall Notification letter to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Lanx Customer Service.
Quantity in commerce: 1999
Distribution: Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MO, NC, NE, NY, OH, OR, PA, TN, TX, VA, WI. and the countries of: Italy, and Mexico.
Product codes and lots: LOT Numbers: L561968 and L570545 Product Code: 77031600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1146-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1146-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-24

Product code NKB

K122145Class IILanx Spinal Fixation SystemLanx, Inc. / cleared 2012-08-17

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)