The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1146-2015·Announced 2015-03-04

Biomet Spine Recalls Out-of-Specification 5.5 mm Rod Set Screws

Biomet Spine is recalling 1,999 5.5 mm rod set screws because they are out of specification. The devices are used in spinal fixation constructs.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (out of specification) used in spinal fixation. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Biomet Spine, LLC is recalling 1,999 units of the Set Screw 5.5 mm Rod (Model #7703-1600). The recall is due to the set screws being out of specification. The affected lot numbers are L561968 and L570545.

The titanium alloy set screws are used to seat a 5.5 mm rod into a pedicle screw tulip to create a spinal fixation construct. The devices are provided non-sterile and are used across the Silverton, Silverton-D, and Telluride spinal fixation systems.

The affected units were distributed worldwide, including nationwide in the United States and in Italy and Mexico. No specific instructions for consumers are provided in the source text.

The recalled product

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…
Manufacturer
Biomet Spine, LLC
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
1,999

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • LOT Numbers: L561968 and L570545 Product Code: 77031600

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

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