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 patient's activity. The REPLY device can be programmed to separate pacing and sensing polarities, independent of chamber.
FDA Recall Z-2235-2009 · Posted 2009-09-24
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Recalling Firmela Medical Llc
Recall StatusTerminated
Product CodeNVZ
Date Initiated2008-09-23
Date Terminated2011-12-17
Product Quantity233
Reason for Recall
Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.
Firm 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.
Root Cause
Employee error
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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