FDA Device recall Z-0903-2018
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic su…
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of 2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic su… 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-0903-2018 |
| 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 Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S 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 10-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H311894…Distributed 10-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H311894 3/9/2017 2026-01-31 H311912 3/9/2017 2026-01-31 H311913 3/9/2017 2026-01-31 H311941 3/9/2017 2026-01-31 H311942 3/9/2017 2026-01-31 H311925 3/14/2017 2026-01-31 H311938 3/14/2017 2026-01-31 H311924 4/9/2017 2026-01-31 H334430 4/13/2017 2026-02-28 H334555 4/13/2017 2026-02-28 H334556 4/19/2017 2026-02-28 H336080 4/19/2017 2026-03-31 H336081 4/19/2017 2026-03-31 H336083 4/19/2017 2026-03-31 H317169 5/10/2017 2026-03-31 H317170 5/10/2017 2026-03-31 |
|---|
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-0903-2018%22
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