Recall Z-2339-2018 ยท MDM Instrument, Manual, Surgical, General Use
Trilliant Surgical Ltd.
Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
| Date | Mar 27, 2018 |
| Status | Terminated |
| Reason | Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft. |
| Root cause | Other |
| Action | On 03/27/18, the firm sent Medical Device Recall notices to customers informing them to: 1) Check inventory stock for identified devices; 2) Locate and remove and/or discontinue use of identified devices; 3) Return all related product(s) to the firm in accordance with an included return response / acknowledgement form. Customers were instructed to contact the firm at 1-800-495-2919 to organize product returns. |
| Quantity | 90 |
| Distribution | U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.