Data Foundry

Medical device recalls 2021

OPTETRAK Comprehensive Knee System — Class II medical device recall Z-0019-2022

Ongoing recall by Exactech, Inc., reported 2021-10-13, distributed nationwide. Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Recall numberZ-0019-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmExactech, Inc., Gainesville, FL, United States
Recall initiated2021-08-30
Classified2021-10-04
Reported by FDA2021-10-13
DistributedNationwide (US)
Countries outside the USAR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CY, DE, DZ, EC, ES, FR, GB, GH, GR, GT, IN, IT, JO, JP, KR, LB, LU, MX, MY, NL, NZ, PL, PT, RO, SG, TH, TN, TR, VE
Quantity242,397 devices
UPC / GTIN / UDI-DI10885862039934, 10885862039965, 10885862039972, 10885862039989, 10885862039996, 10885862040008, 10885862040015, 10885862040039, 10885862040046, 10885862040053, 10885862040077, 10885862040084, 10885862040091, 10885862040121, 10885862040138, 10885862040145, 10885862040152, 10885862040169, 10885862040176, 10885862040183, 10885862040190, 10885862040206, 10885862040213, 10885862040220, 10885862040237 and 244 more
Serial numbers0558856, 0558857, 0558858, 0558859, 0558860, 0558861, 0558863, 0558865, 0558867, 0558868, 0558869, 0558870, 0558871, 0558872, 0558873, 0558874, 0558875, 0558876, 0558877, 0558878, 0558879, 0558881, 0558882, 0558883, 0558884 and 475 more

Product

OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0019-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.