🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: March 8, 2019 ulrich medical USA Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ulrich medical USA Inc
Reason for Recall:
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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 Codes/Lot 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.

Distribution:

Distributed in: AZ, IL, LA, MI, MO, NV, OH, PA, TN, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1126-2019

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Ulrich Medical USA

Class I - Dangerous

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