Pioneer Surgical Technology Recalls Streamline CT Set Screws
Pioneer Surgical Technology is recalling 11 sets of Streamline CT Cervico-Thoracic System set screws because some thread profiles were not within specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Pioneer Surgical Technology, Inc. is recalling 11 sets of the Streamline CT Cervico-Thoracic System set screws (Ref 26-SETSCREW). The product is non-sterile, single-use, and prescription-only.
The recall was initiated because some set screw thread profiles were found not to be within specifications. The affected units are distributed in North Carolina, New Hampshire, New York, California, Michigan, Illinois, and Florida. The specific lot numbers involved are 104875, 104876, 104877, 104878, 104879, 104880, 104881, 117030, 117031, 121947, and 124260.
Healthcare providers and facilities should stop using the affected set screws and contact Pioneer Surgical Technology for further instructions.
The recalled product
- Product
- STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
- Manufacturer
- PIONEER SURGICAL TECHNOLOGY, INC.
- Hazard
- Affected units
- 11
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 (11)
- Lot numbers: 104875
- 104876
- 104877
- 104878
- 104879
- 104880
- 104881
- 117030
- 117031
- 121947
- 124260.
Distribution
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