FDA Device recall Z-0838-2018
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile by Stryker, citing 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 instrument….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0838-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-17 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker |
| Distribution | n/a |
Product
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
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.
Identifiers
| code_info | Model 0234020280, UDI 07613154643264, Lot No. 17299AG2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0838-2018%22
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