CLASS II Device recall · Reported 17 Apr 2019 · FDA Enforcement Report

Ulrich Torque Limiting Handle for use recalled by ulrich medical USA

ulrich medical USA is recalling Ulrich Torque Limiting Handle for use with a Set Screw Driver to perform the final, distributed in 10 states. The recall was initiated on 8 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #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.

Quantity recalled25

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1126-2019
FDA event ID: 82497
Recalling firm: ulrich medical USA, Chesterfield, MO
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2019
FDA classified: 11 Apr 2019
Reported: 17 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

8 Mar 2019	Recall initiated by company
11 Apr 2019	Classified by FDA	+34 days
17 Apr 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.

Arizona Illinois Louisiana Michigan Missouri Nevada Ohio Pennsylvania Tennessee Texas

Questions about this recall

Is Ulrich Torque Limiting Handle for use with a Set Screw Driver to perform the final recalled?

Yes. ulrich medical USA recalled Ulrich Torque Limiting Handle for use with a Set Screw Driver to perform the final on 8 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1126-2019.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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