ulrich medical USA Inc: Medical Device Recall in 2019 - (Recall #: Z-1126-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.

Product Classification:

Class II

Date Initiated: March 8, 2019

Date Posted: April 17, 2019

Recall Number: Z-1126-2019

Event ID: 82497

Reason for Recall:

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

Status: Terminated

Product Quantity: 25

Code Information:

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.

Distribution Pattern:

AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated