Ulrich Medical Recalls Spinal Locking Screws Due to Weld Seam Defect
Ulrich medical USA Inc is recalling 179 units of neon3 OCT spinal stabilization locking screws because a production error prevents them from reliably transmitting required torque.
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 is classified as FDA Class II and involves a structural defect in a medical device that could lead to improper installation, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ulrich medical USA Inc is recalling 179 units of the neon3 OCT spinal stabilization locking screw for crosslink, screw-to-screw (REF CS 3917-12). The recall involves lot numbers U010577, U016620, and U019084. The affected products were distributed in Arizona, Texas, Georgia, Florida, Arkansas, and California.
The recall was initiated due to a production error affecting the weld seam of the locking screws. This defect means the screws cannot reliably transmit the required torque of 3.5 Nm during installation. The agency has classified this as a Class II recall.
Healthcare facilities and consumers who have these specific products should stop using them and contact Ulrich medical USA Inc for instructions on return or replacement. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
- Manufacturer
- ulrich medical USA Inc
- Affected units
- 179
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 (3)
- Lot Numbers: U010577
- U016620
- U019084
Distribution
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