Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee art
FDA device recall Z-0165-2016 · posted 2015-10-26 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- The labeling is missing the size/diameter information.
- Action taken
- DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- OIY
- Quantity affected
- 209 units
- Distribution
- US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.
- Date initiated
- 2015-09-16
- Date posted
- 2015-10-26
- Date terminated
- 2016-01-04
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPRT REVISION KNEE (K140830) | Encore Medical L.P. | 2014-07-11 |