ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
This recall has been completed (originally issued November 28, 2018).
- Recall Initiated
- November 28, 2018
- Recall Number
- Z-0790-2020
- Quantity
- 274 devices
- Firm Location
- Thousand Oaks, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Distribution
Distribution was made to AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, and VA. There was no government/military distribution. Foreign distribution was made to Canada, Armenia, Australia, Denmark, France, Germany, Great Britain, Iceland, Italy, Lithuania, Netherlands, Poland, Spain, Sweden, and Switzerland.
Lot / Code Info
Lot numbers 104479 and 104963.
Root Cause
Process control
Action Taken
The firm first issued recall letters on 11/28/2018 via FedEx for Part number 6534-09PT and then on 12/28/2018, issued recall letters for Part number 6530-09PT via FedEx. On 2/14/2019, the firm issued another letter to their consignees that added a risk statement regarding the recall of both part numbers (6534-09PT and 6530-09PT).