Z-1225-2022 Class II Terminated
FDA device recall Z-1225-2022 was initiated by MicroPort Orthopedics Inc. on May 4, 2022 and is designated Class II. Reason for recall: One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. The recall status is terminated (terminated January 16, 2024). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2022
- Initiation Date
- May 4, 2022
- Termination Date
- January 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
Reason for Recall
One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
Code Information
Catalog Number(s): PHAPCLS7; Lot Number(s): 1903727; Expiration Date: 11/24/2029; UDI/DI Number: 00192629112773