Class 2 Device Recall ULRICH Torque Limiting HandleTorque Wrench

• Date Initiated by Firm: March 08, 2019
• Create Date: April 11, 2019
• Recall Status: Terminated on July 10, 2020
• Recall Number: Z-1126-2019
• Recall Event ID: 82497
• 510(K)Number: K102853 K123717 K161032
• Product Classification: Valve, shunt, fluid, central nervous system (post-amendment design) - Product Code LXL
• 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.
• 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.
• FEI Number: 3005532635
• Recalling Firm/ Manufacturer: ulrich medical USA Inc; 18221 Edison Ave; Chesterfield MO 63005-3703
• For Additional Information Contact: Louis J. Milos; 636-519-0268 Ext. 105
• Manufacturer Reason for Recall: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
• FDA Determined Cause: Storage
• Action: On March 13 , 2019 the firm sent letters to their consignees stating the following: The purpose of this letter is to advise you that ulrich medical USA is voluntarily recalling certain Torque Limiting Handles. Reason for the voluntary recall: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. The calibration issue experienced to date has been limited to select instruments and not all of these instruments have been affected. Due to the nature of how these instruments are used the risk to the patient is low. No injury or death has been reported. Risk to health: Over or under tightening of the set screw could cause the construct to fatigue or loosen. The risk to the patient is low. Actions to be taken by the user: Return the torque limiting handles to ulrich medical USA at ulrichs expense, and a new torque limiting handle will be shipped back. Instructions for acknowledgement of receipt include FedEx signature required. Actions to be taken by the Company: All affected instruments will be replaced with new torque limiting handle upon return. Contact information: If you have any questions or concerns please contact: Louis Milos Sr. Manager Business and Quality Systems 18221 Edison Ave. Chesterfield, MO 63005 636-519-0268 ext. 105 l.milos@ulrichmedicalusa.com www.ulrichmedicalusa.com Available Monday through Friday 8:00am to 5:00pm CST
• Quantity in Commerce: 25
• Distribution: AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LXL