Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi i
FDA device recall Z-1453-2015 · posted 2015-04-16 · Terminated
Recall details
- Recalling firm
- US Endoscopy Group Inc
- Reason for recall
- A wire component on the distal grasping assembly of the device became detached..
- Action taken
- On 03/25/2015 the firm sent recall notification letters to their customers via email.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- OCZ
- Quantity affected
- 1695 units
- Distribution
- Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA,
- Date initiated
- 2015-03-10
- Date posted
- 2015-04-16
- Date terminated
- 2016-10-27
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (K962676) | United States Endoscopy Group, Inc. | 1996-10-04 |