Providence Medical Technologies Recalls Ally Bone Screws Due to Dimensional Error
Providence Medical Technologies is recalling 208 units of Ally Bone Screws due to a potential dimensional manufacturing error that poses a safety risk to patients.
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 potential safety risk to patients, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Providence Medical Technologies is recalling 208 units of Ally Bone Screws. The recall is due to a potential dimensional manufacturing error that represents a safety risk to patients. The affected products are intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation.
The recall includes specific model numbers and lot numbers: Model PD 32 601 (Lot 046164) and Model PD 32 602 (Lots 045375, 045646, 045647, 046313). These devices are distributed nationwide in the United States, including in Arizona, California, Florida, Illinois, Indiana, Louisiana, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, and Texas.
Healthcare providers and patients should stop using the affected devices and contact Providence Medical Technologies for further instructions. The devices are intended for single use only.
The recalled product
- Product
- Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical…
- Manufacturer
- PROVIDENCE MEDICAL TECHNOLOGIES
- Affected units
- 208
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)
- Model Number
Distribution
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