Recall Z-2605-2018 ยท OLO Orthopedic Stereotaxic Instrument
Think Surgical, Inc.
Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.
| Date | Mar 30, 2018 |
| Status | Terminated |
| Reason | There is a potential for the cutter head to detach from the cutter shaft. |
| Root cause | Process control |
| Action | The firm, Think Surgical Inc., sent an "Urgent Medical Device Recall" notices dated 3/30/2018 to customers on 3/30/18. The notices instructed customers to perform the following actions: Examine your inventory, locate any unused devices noted above and quarantine them immediately. If you have received any accessory kits from THINK surgical Incorporated with the noted cutter part numbers included, do not use any affected product and return any unused product to the company. THINK Surgical Incorporated has provided you with a Returned Material Authorization Form (RMA), a FedEx Envelope and re |
| Quantity | 951 |
| Distribution | The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.