Ulrich Torque Limiting Handles Recalled for Exceeding Calibration Life
Ulrich Medical USA Inc. is recalling 25 Torque Limiting Handles because they are beyond their 3-year calibration life.
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 involves a calibration expiration issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ulrich Medical USA Inc. is recalling 25 units of the Ulrich Torque Limiting Handle. This device is used with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
The recall is being conducted because certain Torque Limiting Handles in the field are beyond their 3-year calibration life. The affected units were distributed to facilities in Arizona, Illinois, Louisiana, Michigan, Missouri, Nevada, Ohio, Pennsylvania, Tennessee, and Texas.
Healthcare providers should stop using the affected devices and contact Ulrich Medical USA Inc. for further instructions. The recall covers specific model and serial numbers, including Model #s CS 7130, CS 7134, CS 7146, CS 7148, and CS 8049.
The recalled product
- Product
- ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
- Manufacturer
- ulrich medical USA Inc
- Hazard
- Affected units
- 25
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 (9)
- Model #s CS 7148 Serial #s 11-12-035-01_09
- 03-12-006-24
- and 03-12-006-25 (11 total) UDI Description 4052536078318
- and Model #s CS 8049 Serial #s J04192-31_40
- J04192-056
- J04192-064
- H12015-031_6
- and J01276-031_3
- (21 total) UDI Description 4052536022076.
Distribution
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