Class 1 Device Recall PowerProMax

• Date Initiated by Firm: July 31, 2009
• Date Posted: October 01, 2009
• Recall Status: Terminated on December 19, 2011
• Recall Number: Z-1951-2009
• Recall Event ID: 52803
• 510(K)Number: K981269
• Product Classification: Battery Single Trigger - Product Code HRX
• Product: PowerProMax PRO5100M Battery Single Trigger,; ; PowerProMax PRO5200M Battery Two Trigger,; ; PowerProMax PRO5250M Battery Two-Trigger Standard,; ; PowerProMax PRO5300M Battery Oscillator,; ; PowerProMax PRO5400M Battery Reciprocator, and; ; PowerProMax PRO6200 Battery Single Trigger.; ; CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
• Code Information: PowerProMax PRO5300M Battery Oscillator, BBB96911 BBB96912 BBB96913 BBB96914 BBB96916 BBB97047 BBB97048 BBB97052 BBB97053 BBB97054 BBB97338 BBB97339 BBB97341 BBB97342 BBB97344 BBB97433 BBB97434 BBB97435 BBB97436 BBB97438 BBB97902 BBB97903 BBB97904 BBB97905 BBB97906 BBB97909 BBB97911 BBB97912 BBB97913 BBB97915 BBB97918 BBB97919 BBB98640 BBB98641 BBB98642 BBB98644 BBB98645 BBB98647 BBB98648 BBB98649 BBB98650 BBB98652 BBB98654 BBB98919 BBB99629 BBB99630 BBB99633 BBB99634 BBB99856 BBB99858 BBB99862 BBC00126 BBC00127 BBC00128 BBC00130 BBC00131 BBC00132 BBC00133 BBC00344 BBC00345 BBC00346 BBC00347 BBC00348 BBC00349 BBC00350 BBC00351 BBC00474 BBC00477 BBC00478 BBC00480 BBC00634 BBC00635 BBC00637 BBC00638 BBC00639 BBC00640 BBC00899 BBC00902 BBC00985 BBC00986 BBC00987 BBC00988 BBC00989 BBC01548 BBC01549 BBC01550 BBC01552 BBC01553 BBC01554 BBC01555 BBC01899 BBC01900 BBC01901 BBC01902 BBC01903 BBC02125 BBC02126 BBC02127 BBC02128 BBC02131 BBC02342 BBC02343 BBC02344 BBC02345 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EXPANDED RECALL: PRO5100M POWERPROMAX SINGLE TRIGGER BATTERY HP 00001049 * 00001052 * 00001056 * 00001057 * 00001066 * 00001067 * 00001069 * 00001070 * 00001075 * 00001079 * 00001086 * 00001092 * 00001097 * 00001100 * 00001102 * 00001105 * 00001130 * 00001132 * 00001134 * 00001135 * 00001136 * 00001137 * 00001146 * 00001150 * 00001155 * 00001156 * 00001157 * 00001166 * 00001169 * 00001175 * 00001187 * 00001202 * 00001206 * 00001228 * 00001229 * 00001241 * 00001253 * 00001255 * 00001306 * 00001323 * 00001337 * 00001383 * 00001387 * 00001392 * 00001397 * 00001402 * 00001406 * 00001412 * 00001415 * 00001416 * 00001423 * 00001424 * 00001434 * 00001438 * 00001453 * 00001466 * 00001480 * 00001483 * 00001485 * 00001486 * 00001487 * 00001516 * 00001534 * 00001556 * 00001567 * 00001581 * 00001582 * 00001599 * 00001604 * 00001611 * 00001650 * 00001677 * 00001700 * 00001707 * 00001728 * 00001763 * 00001803 * 00001805 * 00001806 * 00001816 * 00001818 * 00001834 * 00001835 * 00001836 * 00001840 * 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• Recalling Firm/ Manufacturer: Linvatec Corp. dba ConMed Linvatec; 11311 Concept Blvd; Largo FL 33773-4908
• For Additional Information Contact: 727-392-6464
• Manufacturer Reason for Recall: There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.
• FDA Determined Cause: Device Design
• Action: Consignees were notified via letter by FedEx delivery or equivalent method. If the product has been further distributed the consignee is requested to notify their consignees. The letter indicated the following risk mitigation actions until affected handpieces are returned to the manufacturer for preventive maintenance: 1) Apply supplied label to the identified handpieces by specific serial number, 2) If self-activation is experienced, discontinue use immediately and return to ConMed Linvtec and 3) Advise/remind the consignee to follow the manufacturers preventive maintenance intervals specified in the instructions for use manuals. Direct questions to ConMed Linvatec at 1-800-237-0169. Recall Expansion: New amended customer and distributor letters will be sent to those identified customer/distributor accounts. The letter will address the additional units.
• Quantity in Commerce: 5,553 (4,235 INITIAL AND 1,318 EXPANDED)
• Distribution: Worldwide Distribution including United States.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HRX and Original Applicant = LINVATEC CORP.