OPTETRAK Comprehensive Knee System custom devices recall
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX)…
Why was OPTETRAK Comprehensive Knee System custom devices recalled?
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. 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)
- Product
- OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX)…
- Recalling firm
- Exactech, Inc.
- Quantity
- 41 devices
- Distribution
- 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 .
- Recall date
- October 13, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)