Stryker Recalls Static Inserter Assemblies Due to Weld Fracture Complaints
Stryker Spine is recalling 21 units of Specialty Straight Static Inserter Assemblies because customers reported fractures along the weld binding the handle to the shaft.
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 structural defect (weld fracture) in a medical device used for spinal surgery. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' as the source text mentions complaints of fracture but does not explicitly state that patient injuries or illnesses occurred.
Plain-English summary
Stryker Spine is recalling 21 units of the Specialty Straight Static Inserter Assembly. This instrument is part of the Navigator product brand and is used for implant insertion into the disc space as part of the AVS Navigator Peek Spacer System for spinal fixation.
The recall was initiated after Stryker received complaints from customers regarding fractures along the weld that binds the handle to the shaft of the static inserter. The affected units were distributed nationwide in the United States.
The specific units involved are identified by Catalog # IS3009AVS and Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195, and 4242. Users should stop using these specific instruments and contact Stryker Spine for further instructions.
The recalled product
- Product
- Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for…
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 21
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 (6)
- D109140 Catalog # IS3009AVS Lot Serial # 3664
- 3759
- 3843
- 3913
- 4079
- 4195 and 4242
Distribution
Distributed nationwide across the United States.
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