FDA recall Z-2865-2020

Product

ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Distribution

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2020-07-22

Report date

2020-09-02

Termination date

2021-08-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Audubon, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2865-2020