ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280… recallZ-0838-2018 · Stryker Corporation · initiated Nov 17, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0838-2018
- Status
- Terminated
- Initiated by the company
- Nov 17, 2017
- Recalling firm
- Stryker Corporation
- Quantity
- 60,753 units total
- Product code
- KDD
- Distribution
- Distributed domestically to . Distributed internationally to Australia and Mexico.
Product description
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Code information (models, lots, serial numbers)
Model 0234020280, UDI 07613154643264, Lot No. 17299AG2
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 234-020-280Stryker Corporation · KIT, SURGICAL INSTRUMENT, DISPOSABLE1 recall2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 78668).
- Z-0835-2018 · TerminatedStrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION …
- Z-0836-2018 · TerminatedSTRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packagi…
- Z-0837-2018 · TerminatedSTRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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