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Sorin Group Reply DR Rate responsive dual-chamber… recallZ-2235-2009 · ela Medical Llc · initiated Sep 23, 2008

Terminated All recalls posted in September 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ela Medical Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-2235-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 23, 2008
Posted by the FDA
Sep 24, 2009
Recalling firm
ela Medical Llc
Quantity
233
Product code
NVZ
FDA submissions
P950029
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.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

serial numbers:  816ZA225 816ZA230 816ZA824 817ZA064 817ZA108 817ZA290 817ZA340 817ZA346 817ZA944 818ZA089 818ZA399 818ZA440 818ZA578 818ZA592 818ZA680 818ZA698 818ZA702 820ZA024 820ZA160 820ZA228 820ZA251 820ZA303 820ZA350 820ZA391 820ZA442 820ZA450 820ZA502 820ZA504 820ZA516 820ZA562 820ZA587 820ZA645 820ZA674 820ZA684 820ZA690 820ZA696 820ZA697 820ZA710 823ZA011 823ZA041 823ZA077 823ZA159 823ZA163 823ZA166 823ZA200 823ZA201 823ZA205 823ZA208 823ZA211 823ZA226 823ZA235 823ZA238 823ZA239 823ZA245 823ZA246 823ZA254 823ZA255 823ZA257 823ZA258 823ZA301 823ZA361 823ZA368 823ZA378 823ZA382 823ZA419 823ZA428 823ZA430 823ZA505 823ZA512 823ZA553 823ZA563 823ZA570 823ZA581 823ZA640 823ZA646 823ZA650 823ZA700 823ZA707 823ZA708 823ZA716 823ZA718 823ZA723 823ZA739 823ZA743 823ZA754 823ZA755 823ZA764 823ZA776 823ZA777 823ZA780 823ZA785 823ZA790 823ZA795 823ZA801 823ZA809 823ZA810 823ZA816 823ZA883 824ZA001 824ZA032 824ZA077 824ZA079 824ZA085 824ZA088 824ZA089 824ZA095 824ZA124 824ZA125 824ZA126 824ZA155 824ZA158 824ZA159 824ZA178 824ZA190 824ZA200 824ZA223 824ZA224 824ZA240 824ZA241 824ZA244 824ZA251 824ZA263 824ZA264 824ZA265 824ZA270 824ZA272 824ZA278 824ZA284 824ZA285 824ZA286 824ZA288 824ZA289 824ZA293 824ZA304 824ZA307 824ZA308 824ZA310 824ZA311 824ZA312 824ZA315 824ZA358 824ZA361 824ZA363 824ZA364 824ZA366 824ZA367 824ZA368 824ZA374 824ZA375 824ZA376 824ZA377 824ZA390 824ZA428 824ZA464 824ZA468 824ZA471 824ZA472 824ZA473 824ZA546 824ZA601 824ZA626 824ZA657 824ZA695 824ZA702 824ZA704 824ZA830 824ZA831 824ZA839 824ZA883 824ZA921 824ZA960 824ZA979 824ZA980 824ZA991 825ZA219 825ZA274 825ZA360 825ZA381 825ZA405 825ZA412 825ZA431 825ZA448 825ZA472 825ZA529 825ZA542 825ZA596 825ZA607 825ZA613 825ZA716 825ZA787 825ZA814 825ZA849 825ZA927 825ZA937 826ZA061 826ZA121 826ZA289 826ZA291 826ZA293 826ZA294 826ZA321 826ZA323 826ZA324 826ZA358 826ZA414, and 826ZA479.

Other devices under the same FDA submission

5 devices cleared under P950029 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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