Stryker Corporation: Medical Device Recall in 2018 - (Recall #: Z-0838-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

Product Classification:

Class II

Date Initiated: November 17, 2017

Date Posted: March 14, 2018

Recall Number: Z-0838-2018

Event ID: 78668

Reason for Recall:

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.

Status: Terminated

Product Quantity: 60,753 units total

Code Information:

Model 0234020280, UDI 07613154643264, Lot No. 17299AG2

Distribution Pattern:

Distributed domestically to . Distributed internationally to Australia and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated