Set Screw 5 — Class II medical device recall Z-1146-2015
Terminated recall by Biomet Spine, LLC, reported 2015-03-04, distributed nationwide. Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
| Recall number | Z-1146-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet Spine, LLC, Broomfield, CO, United States |
| Recall initiated | 2012-11-30 |
| Classified | 2015-02-24 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2015-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT, MX |
| Quantity | 1,999 |
| Reason classes | specification failure |
| Lot numbers | L561968, L570545 |
| Model numbers | 7703-1600 |
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 for recall
Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1146-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.