Recall Z-2320-2016 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
RePlant Angled Abutment Part Number 6050-52-60
| Date | Aug 2, 2016 (initiated Jul 5, 2016) |
| Status | Terminated |
| Reason | Issue with design specification; oversized condition. |
| Root cause | Process control |
| Action | Implant Direct sent an Urgent: Medical Device Field Corrective Action letter dated July 6, 2016, to all affected customers. The letter requests that it be reviewed and determined if customer has any affected product in inventory. Customers are asked to complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized Implant Direct Sybron Manufacturing distributor, they request that customers identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48 |
| Quantity | 205 |
| Distribution | U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061319 | SPECTRA SYSTEM Implant Direct, LLC, Sep 29, 2006 |