Recall Z-2235-2009 ยท NVZ Pulse Generator, Permanent, Implantable
ela Medical Llc
Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14401 West 65th Way, Arvada, CO 80004, USA. REPLY DR is a DDDR-type dual-chamber rate-responsive pacemaker. It is equipped with a physiological sensor and an accelerometer to allow adaptation of pacing to suit the patie
| Date | Sep 24, 2009 (initiated Sep 23, 2008) |
| Status | Terminated |
| Reason | Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew. |
| Root cause | Employee error |
| Action | A Reply Technical Note, dated September 2008, titled Additional Instructions for use at Implant for REPLY pacemakers, was issued to physicians on September 24, 2008. The Technical Note describes the background for an increased incidence of complaints relating to the screwdriver and setscrew. The letter provided a reminder for inserting the screwdriver, and additional instructions for insertion of the screwdriver. |
| Quantity | 233 |
| Distribution | Nationwide Distribution -- USA, including states of AL, AZ, CA, CO, CT, FL, GA, KS, KY, LA, MA, MI, NC, NJ, OH, OK, SC, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.