Exactech, Inc. Recall 88570
Description: OPTETRAK Comprehensive Knee System including OPTETRAK Logic All-polyethylene Tibial Components, also labeled as the following: a. OPTETRAK Logic All-polyethylene CR Tibial Components; b. OPTETRAK Logic All-polyethylene CRC Tibial Components; c. OPTETRAK Logic All-polyethylene PSC Tibial Components;
Exactech, Inc. Recall 88570 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0021-2022 |
| Event ID | 88570 |
| Event Description | OPTETRAK Comprehensive Knee System including OPTETRAK Logic All-polyethylene Tibial Components, also labeled as the following: a. OPTETRAK Logic All-polyethylene CR Tibial Components; b. OPTETRAK Logic All-polyethylene CRC Tibial Components; c. OPTETRAK Logic All-polyethylene PSC Tibial Components; |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution to the states of AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of Australia, France, Germany, Japan, Spain, UK. |
| Quantity | 41,028 devices |
| Recall Reason | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Device Classification | 20211013 |
| Device Code Info | a. Item Number (Device Identifier): 02-012-47-0009 (10885862174031), 02-012-47-0011 (10885862174048), 02-012-47-0013 (10885862174055), 02-012-47-0015 (10885862174062), 02-012-47-0017 (10885862248220), 02-012-47-1009 (10885862174130), 02-012-47-1011 (10885862174147), 02-012-47-1013 (10885862174154), 02-012-47-1015 (10885862174161), 02-012-47-1017 (10885862248244), 02-012-47-1509 (10885862144331), 02-012-47-1511 (10885862144348), 02-012-47-1513 (10885862144355), 02-012-47-1515 (10885862144362), 02-012-47-1517 (10885862248268), 02-012-47-2009 (10885862174246), 02-012-47-2011 (10885862174253), 02-012-47-2013 (10885862174260), 02-012-47-2015 (10885862174277), 02-012-47-2017 (10885862248282), 02-012-47-2509 (10885862159144), 02-012-47-2511 (10885862159151), 02-012-47-2513 (10885862159168), 02-012-47-2515 (10885862159175), 02-012-47-2517 (10885862248305), 02-012-47-3009 (10885862174345), 02-012-47-3011 (10885862174352), 02-012-47-3013 (10885862174369), 02-012-47-3015 (10885862174376), 02-012-47-3017 (10885862248329), 02-012-47-3509 (10885862159243), 02-012-47-3511 (10885862159250), 02-012-47-3513 (10885862159267), 02-012-47-3515 (10885862159274), 02-012-47-3517 (10885862248343), 02-012-47-4009 (10885862174444), 02-012-47-4011 (10885862174451), 02-012-47-4013 (10885862174468), 02-012-47-4015 (10885862174475), 02-012-47-4017 (10885862248367), 02-012-47-5009 (10885862174543), 02-012-47-5011 (10885862174550), 02-012-47-5013 (10885862174567), 02-012-47-5015 (10885862174574), 02-012-47-5017 (10885862248404), 02-012-47-6009 (10885862174642), 02-012-47-6011 (10885862174659), 02-012-47-6013 (10885862174666), 02-012-47-6015 (10885862174673), 02-012-48-0009 (10885862174079), 02-012-48-0011 (10885862174086), 02-012-48-0013 (10885862174093), 02-012-48-1009 (10885862174178), 02-012-48-1011 (10885862174185), 02-012-48-1013 (10885862174192), 02-012-48-1509 (10885862144379), 02-012-48-1511 (10885862144386), 02-012-48-1513 (10885862144393), 02-012-48-2009 (10885862174284), 02-012-48-2011 (10885862174291), 02-012-48-2013 (10885862174307), 02-012-48-2509 (10885862159182), 02-012-48-2511 (10885862159199), 02-012-48-2513 (10885862159205), 02-012-48-3009 (10885862174383), 02-012-48-3011 (10885862174390), 02-012-48-3013 (10885862174406), 02-012-48-3509 (10885862159281), 02-012-48-3511 (10885862159298), 02-012-48-3513 (10885862159304), 02-012-48-4009 (10885862174482), 02-012-48-4011 (10885862174499), 02-012-48-4013 (10885862174505), 02-012-48-5009 (10885862174581), 02-012-48-5011 (10885862174598), 02-012-48-5013 (10885862174604), 02-012-48-6011 (10885862174697), 02-012-48-6013 (10885862174703), 02-012-49-0009 (10885862174109), 02-012-49-0011 (10885862174116), 02-012-49-0013 (10885862174123), 02-012-49-1009 (10885862174208), 02-012-49-1011 (10885862174215), 02-012-49-1013 (10885862174222), 02-012-49-1509 (10885862144409), 02-012-49-1511 (10885862144416), 02-012-49-1513 (10885862144423), 02-012-49-2009 (10885862174314), 02-012-49-2011 (10885862174321), 02-012-49-2013 (10885862174338), 02-012-49-2509 (10885862159212), 02-012-49-2511 (10885862159229), 02-012-49-2513 (10885862159236), 02-012-49-3009 (10885862174413), 02-012-49-3011 (10885862174420), 02-012-49-3013 (10885862174437), 02-012-49-3509 (10885862159311), 02-012-49-3511 (10885862159328), 02-012-49-3513 (10885862159335), 02-012-49-4009 (10885862174512), 02-012-49-4011 (10885862174529), 02-012-49-4013 (10885862174536), 02-012-49-5009 (10885862174611), 02-012-49-5011 (10885862174628), 02-012-49-5013 (10885862174635), 02-012-49-6011 (10885862174796), 02-012-49-6013 (10885862174802); b. Item Number (Device Identifier): 02-012-51-0013 (10885862230188), 02-012-51-0015 (10885862230195), 02-012-51-1009 (10885862230201), 02-012-51-1011 (10885862230218), 02-012-51-1013 (10885862230225), 02-012-51-1015 (10885862230232), 02-012-51-1017 (10885862247803), 02-012-51-1019 (10885862247810), 02-012-51-1509 (10885862230249), 02-012-51-1511 (10885862230294), 02-012-51-1513 (10885862230300), 02-012-51-1515 (10885862230317), 02-012-51-1517 (10885862247827), 02-012-51-2009 (10885862230324), 02-012-51-2011 (10885862230331), 02-012-51-2013 (10885862230348), 02-012-51-2015 (10885862230355), 02-012-51-2017 (10885862247841), 02-012-51-2019 (10885862247858), 02-012-51-2509 (10885862230362), 02-012-51-2511 (10885862230379), 02-012-51-2513 (10885862230386), 02-012-51-2515 (10885862230393), 02-012-51-2517 (10885862247865), 02-012-51-2519 (10885862247872), 02-012-51-3009 (10885862230409), 02-012-51-3011 (10885862230416), 02-012-51-3013 (10885862230423), 02-012-51-3015 (10885862230430), 02-012-51-3017 (10885862247889), 02-012-51-3019 (10885862247896), 02-012-51-3113 (10885862280350), 02-012-51-3115 (10885862280367), 02-012-51-3117 (10885862280374), 02-012-51-3509 (10885862230447), 02-012-51-3511 (10885862230454), 02-012-51-3513 (10885862230461), 02-012-51-3515 (10885862230478), 02-012-51-3517 (10885862247902), 02-012-51-4009 (10885862230485), 02-012-51-4011 (10885862230492), 02-012-51-4013 (10885862230508), 02-012-51-4015 (10885862230515), 02-012-51-4017 (10885862247926), 02-012-51-5009 (10885862230560), 02-012-51-5011 (10885862230577), 02-012-51-5013 (10885862230584), 02-012-51-5015 (10885862230591), 02-012-51-5017 (10885862247964), 02-012-51-6009 (10885862230645), 02-012-51-6011 (10885862230652), 02-012-51-6013 (10885862230669), 02-012-51-6015 (10885862230676), 02-012-51-6017 (10885862247988); c. Item Number (Device Identifier): 02-012-44-0009 (10885862173355), 02-012-44-0011 (10885862173362), 02-012-44-0013 (10885862173379), 02-012-44-0015 (10885862173386), 02-012-44-0017 (10885862248008), 02-012-44-0019 (10885862248015), 02-012-44-1009 (10885862173393), 02-012-44-1011 (10885862173409), 02-012-44-1013 (10885862173416), 02-012-44-1015 (10885862173423), 02-012-44-1017 (10885862248022), 02-012-44-1019 (10885862248039), 02-012-44-1509 (10885862173430), 02-012-44-1511 (10885862173447), 02-012-44-1513 (10885862173454), 02-012-44-1515 (10885862173461), 02-012-44-1517 (10885862248046), 02-012-44-1519 (10885862248053), 02-012-44-2009 (10885862173478), 02-012-44-2011 (10885862173485), 02-012-44-2013 (10885862173492), 02-012-44-2015 (10885862173508), 02-012-44-2017 (10885862248060), 02-012-44-2019 (10885862248077), 02-012-44-2509 (10885862173515), 02-012-44-2511 (10885862173522), 02-012-44-2513 (10885862173539), 02-012-44-2515 (10885862173546), 02-012-44-2517 (10885862248084), 02-012-44-2519 (10885862248091), 02-012-44-3009 (10885862173553), 02-012-44-3011 (10885862173560), 02-012-44-3013 (10885862173577), 02-012-44-3015 (10885862173584), 02-012-44-3017 (10885862248107), 02-012-44-3019 (10885862248114), 02-012-44-3509 (10885862173591), 02-012-44-3511 (10885862173607), 02-012-44-3513 (10885862173614), 02-012-44-3515 (10885862173621), 02-012-44-3517 (10885862248121), 02-012-44-3519 (10885862248138), 02-012-44-4009 (10885862173638), 02-012-44-4011 (10885862173645), 02-012-44-4013 (10885862173652), 02-012-44-4015 (10885862173669), 02-012-44-4017 (10885862248145), 02-012-44-4019 (10885862248152), 02-012-44-5009 (10885862173713), 02-012-44-5011 (10885862173720), 02-012-44-5013 (10885862173737), 02-012-44-5015 (10885862173744), 02-012-44-5017 (10885862248183), 02-012-44-5019 (10885862248190), 02-012-44-6009 (10885862173751), 02-012-44-6011 (10885862173843), 02-012-44-6013 (10885862173874), 02-012-44-6015 (10885862173881), 02-012-44-6017 (10885862248206), 02-012-44-6019 (10885862248213) |
| Center Classification Date | 20211004 |
| Recall Initiation Date | 20210830 |
| Recalling Firm | Exactech, Inc. |
| Initial Notification | Letter |
| Similar To |