NA 234-020-280Recalls & reported problems
Stryker Corporation · ACL DISPOSABLE PACK (6 PER PKG) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154643264), received between May 19, 2020 and Jul 8, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Nov 17, 2017Terminated
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.
Z-0838-2018 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Break1
- Expiration Date Error1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2020Expiration Date Error
IT WAS REPORTED THAT PRODUCT WAS EXPIRED AND USED DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10246701 ↗InjuryMay 19, 2020Break
IT WAS REPORTED THAT THE BROKEN NITINOL WIRE REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10071115 ↗
Other KIT, SURGICAL INSTRUMENT, DISPOSABLE devices
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- Medline Industries, Inc. DYNJ69761Medline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Synergetics 18069WSynergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Synergetics 18060Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ68217AMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ80200BMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ39461JMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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