FDA Device recall Z-0905-2018
2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedi…
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedi… by Synthes Usa Products, citing possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0905-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-26 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Reason
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Identifiers
| code_info | Distributed 31-May-217 to 20-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H354470 5/27/2017 2026-04-30 |
|---|
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-0905-2018%22
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