FDA Medical Device Recalls (openFDA)
ulrich medical USA Inc: ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
- Recall number
- Z-1126-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-03-08
- Posted
- not on file
- Terminated
- 2020-07-10
- Reason
- Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
- 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 l.milos@ulrichmedicalusa.com www.ulrichmedicalusa.com Available Monday through Friday 8:00am to 5:00pm CST
- Quantity
- 25
- Distribution
- AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K102853","K123717","K161032"]
- PMA numbers
- not on file
- Product code
- LXL
- Firm FEI
- 3005532635
- Firm city
- Chesterfield
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28