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uCentum recallZ-1126-2019 · ulrich medical USA Inc · initiated Mar 8, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ulrich medical USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Storage

What the company is doing

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

Recall details

Recall number
Z-1126-2019
Status
Terminated
Initiated by the company
Mar 8, 2019
Recalling firm
ulrich medical USA Inc
Quantity
25
Product code
LXL
FDA submissions
K102853, K123717, K161032
Distribution
AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.

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.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

39 devices cleared under K102853, K123717, K161032 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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