Z-0027-2022 Class II Ongoing
FDA device recall Z-0027-2022 was initiated by Exactech, Inc. on August 30, 2021 and is designated Class II. Reason for recall: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. The recall status is ongoing. Affected quantity: 12 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- August 30, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 devices
Product Description
Reason for Recall
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 .