FDA Device recall Z-0837-2018
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile by Stryker, citing routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0837-2018 |
| 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
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Reason
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Identifiers
| code_info | Model 0234010056, UDI 04546540754561, Lot No. 17278AG2 |
|---|
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-0837-2018%22
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