Z-1078-2024 Class II Ongoing
FDA device recall Z-1078-2024 was initiated by Zimmer Surgical Inc on January 2, 2024 and is designated Class II. Reason for recall: Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary. The recall status is ongoing. Affected quantity: 76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2024
- Initiation Date
- January 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of CA, DE, FL, GA, IA, IL, IN, KS, LA, MI, MO, MT, NC, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV and the countries of AUTRALIA, CANADA, DNIPRO OBLAS, HONG KONG, INDIA, JAPAN, MEXICO, CDMX, NETHERLANDS, SEOUL KOREA, SINGAPORE, TAIWAN, THAILAND.