Reported Apr 17, 2019 · Terminated
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal…
ulrich medical USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ulrich medical USA Inc · 18221 Edison Ave · Chesterfield, MO · 63005-3703
Is this the product you have?
- ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
- Lot codes and dates
- 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.
- Amount recalled
- 25
Where it was sold
Why it was recalled
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new ulrich medical USA Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.