Acumed LLC: Medical Device Recall in 2017 - (Recall #: Z-1019-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.

Product Classification:

Class II

Date Initiated: December 5, 2016

Date Posted: January 18, 2017

Recall Number: Z-1019-2017

Event ID: 75904

Reason for Recall:

OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification.

Status: Terminated

Product Quantity: 83 units distributed in the US

Code Information:

lot 549/12.001. Part number 65-0210-S.

Distribution Pattern:

distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated