ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
Check against the official notice below — it lists the full affected range.
Ulrich Medical USA Inc. is recalling 25 Torque Limiting Handles used with set screw drivers for tightening set screws in spinal implant constructs. The handles being recalled are beyond their 3-year calibration life. The affected devices include five different models (CS 7130, CS 7134, CS 7146, CS 7148, and CS 8049) with specific serial numbers, and they were distributed to healthcare facilities in Arizona, Illinois, Louisiana, Michigan, Missouri, Nevada, Ohio, Pennsylvania, Tennessee, and Texas.
The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Reason for recall: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. Distribution: AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX. Quantity: 25 Lot/code info: Model #s CS 7130 Serial #s 538436-02_70 (69 total) UDI Description 4052536123704, Model #s CS 7134 Serial #s 538438-02_70 (69 total) UDI Description 4052536123728, Model #s CS 7146 Serial #s 04-14-022-18_23 (6 total) UDI Description4052536078301, 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.