Z-1126-2019Class II

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

Name: Z-1126-2019 ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws...
Creator: ulrich medical USA Inc
Published: 2019-03-08
License: https://open.fda.gov/license/

ulrich medical USA Inc / initiated 2019-03-08 / Terminated / root cause: manufacturing process

FDA source

ulrich medical USA Inc began a recall of ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct on 2019-03-08. FDA classified it as Class II and gives the reason as "Certain Torque Limiting Handles in the field are beyond their 3 year calibration life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1126-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-08
Posted: 2019-04-11
Terminated: 2020-07-10
Recalling firm: ulrich medical USA Inc
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.
Product code: LXL
Reason for recall: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Root cause tag: manufacturing process
FDA root 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 [email protected] 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1126-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1126-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-11

Product code LXL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)