Howmedica Recalls Reliance LITe Nerve Hooks Due to Shape Defects
Howmedica Osteonics Corp. is recalling 39 units of Reliance LITe Nerve Hooks because the probes have incorrect shapes, including flat surfaces and sharp edges.
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 physical defect (sharp edges/incorrect shape) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling 39 units of the Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip (REF # 48066103). The recall affects specific lots: 183432, 183433, 183434, and 17E168. These medical devices are used for nerve retraction during spinal procedures such as discectomy and TLIF.
The recall was initiated because the probes were observed to have incorrect geometric shapes. Instead of having a spherical diameter, the probes have two radii and a flat surface. Additionally, some parts exhibited an edge on the intersection between the radius and the diameter of the probe.
The affected units were distributed worldwide, including in the United States (Pennsylvania) and in Australia, Canada, France, Italy, the Netherlands, Poland, and Spain. Healthcare providers and facilities should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 39
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 (4)
- Lot #s 183432
- 183433
- 183434
- 17E168
Distribution
Distributed in 1 state:
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