Ortho Solutions Recalls UltOS 3.5mm Locking Screws Due to Manufacturing Defect
Ortho Solutions Inc is recalling 875 units of UltOS 3.5mm locking screws because the locking thread feature was not manufactured to specification, creating a risk that the screw may not lock onto the plate.
What this means for you
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 functional defect that could lead to the need for replacement surgery, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Ortho Solutions Inc is initiating a recall of 875 units of UltOS 3.5mm locking screws, ranging in length from 12mm to 50mm. The recall is being conducted because the locking thread feature of the screws was not manufactured to specification.
The defect creates a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. If this occurs, the non-functioning screw would need to be replaced with an alternative. The affected products were distributed in the United States to the states of California, Colorado, Georgia, Illinois, Louisiana, North Carolina, New York, Texas, and Washington.
Healthcare providers and patients should check their inventory and patient records for the specific part numbers and lot numbers listed in the recall notice. If the affected screws have been implanted, the non-functioning screw would need to be replaced with an alternative as indicated in the source text.
The recalled product
- Product
- Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
- Manufacturer
- Ortho Solutions Inc
- Affected units
- 875
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 (15)
- Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891)
- OS421714-NS (lot 7891) OS421716-NS (lot 7891
- 7520)
- OS421718-NS (lot 7891
- 7520) OS421720-NS (lot 7891)
- OS421722-NS (lot 7891
- 7520) OS421724-NS (lot 7891
- OS421726-NS (lot 7891) OS421728-NS (lot 7891)
- OS421730-NS (lot 7891) OS421735-NS (lot 7520
- 7891)
- OS421740-NS (lot 7520
- 7891) OS421745-NS (lot 7520
- OS421750-NS (lot 7520
- 7891) OS421716 (lot 7519)
- OS421718 (lot 7519)
Distribution
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