Recall Z-2339-2018
Trilliant Surgical Ltd. · initiated March 27, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
Codes / lots: Lot: 603600
Reason for recall
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2339-2018
- Initiated
- March 27, 2018
- Terminated
- June 4, 2020
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- 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
- Recalling firm
- Trilliant Surgical Ltd., Houston, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2338-2018 Class II | Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non SterileFirm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a… | 03/27/2018Terminated |