—#189268

Product

ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Item Number (Device Identifier; Serial number(s)): 256-12-02 (No Device Identifier; 1208624, 1208625, 1208626, 1208627); 256-12-03 (10885862066633; 1208774, 1446326); 256-13-02 (No Device Identifier; 1208710, 1208715); 256-13-03 (No Device Identifier; 1208859, 1208863); 256-13-04 (No Device Identifier; 1209010, 1209013)

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

Exactech notified distributors and sales representatives on about 08/30/2021 via letter titled "URGENT MEDICAL DEVICE RECALL." Actions included removing all Knee and Ankle UHMWPE products labeled with an 8-year shelf life and not packaged in EVOH/Nylon bags, in a phased approach over 12 months. Phase 1: immediately return all knee and ankle UHMWPE devices labeled with an 8-year shelf life that will be 5 years old or older by 08/31/2022 not packaged in EVOH/Nylon bags. Phase 2: between 05/31/2022 to 08/31/2022, returning all remaining knee and ankle UHMWPE devices labeled with an 8-year shelf life not packaged in EVOH/Nylon bags. A communication to healthcare professionals should follow. Instructions to recipients included to immediately identify and quarantine any affected product in inventory, notify customers down the line if further distributed, and complete and return the Recall Inventory Response Form to Exactech via email at recalls@exac.com. Exactech expanded their recall and sent an updated notification to US agents and distributors on 02/07/2022. On about 02/08/2022, a letter to surgeons and hospitals was sent. The notifications indicated that all non-conforming devices were included in the recall, to cease use of those devices, and work with sales agents to return any inventory. The letters to surgeons and hospitals also advised physicians regarding follow up with implanted patients.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Worldwide 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 .

Timeline

Recall initiated: 2021-08-30
Posted by FDA: 2021-10-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189268. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.