ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
FDA Recall Z-0838-2018 · Posted None
Recalling FirmStryker Corporation
Recall StatusTerminated
Product CodeKDD
Date Initiated2017-11-17
Date Terminated2024-01-29
Product Quantity60,753 units total
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.
Firm Action
On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email [email protected] to arrange for product return.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed domestically to . Distributed internationally to Australia and Mexico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.