Product Safety Recalls

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Exactech, Inc. Recall 88570

Description: OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Exactech, Inc. Recall 88570 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0022-2022
Event ID88570
Event DescriptionOPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, ROMANIA, SINGAPORE, SPAIN, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, VENEZUELA .
Quantity41 devices
Recall ReasonInserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Device Classification20211013
Device Code Infoa. Item Number (Device Identifier; Serial number(s)): 900-06-18 (10885862100375; 1667962, 1667963); 900-06-20 (10885862100382; 1667796, 1667797); 900-06-22(10885862100399; 1667744, 1667745); 900-08-18 (10885862100405; 1667794, 1667795); 900-08-20 (10885862100412; 1667929, 1667930); 900-08-22 (10885862100429; 1667879, 1667880); b. Item Number (Device Identifier; Serial number(s)): 900-23-02 (10885862100863; 0899804, 0899805, 0899806, 0899807); 900-23-03 (10885862100870; 0900400, 0900401, 0900402, 0900403); 900-23-04 (10885862100887; 0900408, 0900409, 0900410, 0900411, 0900412); 900-23-05 (10885862100894; 0900413, 0900414, 0900415, 0900416); 900-23-06 (10885862100900; 0900404, 0900405, 0900406, 0900407); 900-30-11 (10885862101068; 0565754, 0565755); 900-30-13 (10885862101075; 0565756, 0565757); c. Item Number (Device Identifier; Serial number(s)): 900-33-09 (10885862101082; 1822113, 1822114); 900-33-11 (10885862101099; 1822115, 1822116)
Center Classification Date20211004
Recall Initiation Date20210830
Recalling FirmExactech, Inc.
Initial Notification Letter
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