medical Class II Updated 2019-04-17

ulrich medical USA Inc recalls ULRICH Torque Limiting Handle for use with a Set Screw Drive

Recalled 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.


Hazard / Issue

Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

Issued by

FDA

Affected States: AZ, IL, LA, MI, MO, NV, OH, PA, TN, TX
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.
View official government recall

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