FDA Device recall Z-0904-2018
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during o…
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during o… 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-0904-2018 |
| 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
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S 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 25-Apr-2017 to 22-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H306632…Distributed 25-Apr-2017 to 22-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H306632 4/3/2017 2026-02-28 H311229 4/16/2017 2026-03-31 H311228 4/28/2017 2026-03-31 H311231 4/28/2017 2026-03-31 H319172 4/28/2017 2026-03-31 H319175 4/28/2017 2026-03-31 H318789 5/4/2017 2026-03-31 H319171 5/4/2017 2026-03-31 H327068 5/4/2017 2026-03-31 H311226 5/6/2017 2026-03-31 H311225 5/11/2017 2026-04-30 H311224 5/12/2017 2026-04-30 H327067 5/12/2017 2026-04-30 H327066 5/18/2017 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-0904-2018%22
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