Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescenti
FDA device recall Z-2235-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- ela Medical Llc
- Reason for recall
- Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.
- Action taken
- 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
- Status
- Terminated
- Product code
- NVZ
- Quantity affected
- 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.
- Date initiated
- 2008-09-23
- Date posted
- 2009-09-24
- Date terminated
- 2011-12-17
- Location
- Plymouth, MN
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