CLASS II Device recall · Reported 4 Mar 2015 · FDA Enforcement Report

Set Screw Rod recalled by Biomet Spine

Biomet Spine is recalling Set Screw Rod, distributed nationwide in the US. The recall was initiated on 30 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT Numbers: L561968 and L570545 Product Code: 77031600

Quantity recalled1999

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1146-2015
FDA event ID: 70383
Recalling firm: Biomet Spine, Broomfield, CO
Classification: Class II
Status: Terminated
Recall initiated: 30 Nov 2012
FDA classified: 24 Feb 2015
Reported: 4 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Spinal Implants

Timeline

30 Nov 2012	Recall initiated by company
24 Feb 2015	Classified by FDA	+816 days
4 Mar 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Indiana Kentucky Louisiana Massachusetts Maryland Michigan Missouri North Carolina Nebraska New York Ohio

Questions about this recall

Is Set Screw Rod recalled?

Yes. Biomet Spine recalled Set Screw Rod on 30 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-1146-2015.

Why was it recalled?

Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

Which lots are affected?

LOT Numbers: L561968 and L570545 Product Code: 77031600

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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