FDA Medical Device Recalls (openFDA)
Stryker Corporation: ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
- Recall number
- Z-0838-2018
- Recalling firm
- Stryker Corporation
- Product
- ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
- Status
- Terminated
- Initiated
- 2017-11-17
- Posted
- not on file
- Terminated
- 2024-01-29
- Reason
- 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.
- Root cause
- Under Investigation by 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 endocustomersupport@stryker.com to arrange for product return.
- Quantity
- 60,753 units total
- Distribution
- Distributed domestically to . Distributed internationally to Australia and Mexico.
- Lot, serial or model codes
- Model 0234020280, UDI 07613154643264, Lot No. 17299AG2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDD
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28