Device product
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Z-0569-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 93486
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0569-2024
Official wording
Reason: One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Code information: UDI-DI: 00889024430556; Lot Number: 3145299
Distribution pattern: US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.
Derived failure modes
-
Unknown
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.