FDA Device recall Z-1146-2015
Set Screw 5.5 mm Rod - Model #7703-1600
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of Set Screw 5.5 mm Rod - Model #7703-1600 by Biomet Spine, citing biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1146-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-30 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet Spine |
| Distribution | US |
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.
Reason
Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Identifiers
| code_info | LOT Numbers: L561968 and L570545 Product Code: 77031600 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1146-2015%22
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