FDA Device recall Z-0901-2018
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic sur…
- 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, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic sur… 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-0901-2018 |
| 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, 950 mm, sterile, Part Number: 351.706S 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 21-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H229232…Distributed 21-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H229232 2/14/2017 2026-01-31 H239057 4/9/2017 2026-02-28 H333939 4/9/2017 2026-02-28 H333940 4/9/2017 2026-02-28 H294380 4/16/2017 2026-03-31 H294383 4/16/2017 2026-03-31 H339342 4/18/2017 2026-03-31 H339343 4/18/2017 2026-03-31 H339349 4/18/2017 2026-03-31 H340100 4/18/2017 2026-03-31 H340112 4/18/2017 2026-03-31 H340114 4/18/2017 2026-03-31 H294387 4/19/2017 2026-03-31 H294393 4/19/2017 2026-03-31 H341135 4/19/2017 2026-03-31 H342141 4/19/2017 2026-03-31 H294373 4/21/2017 2026-03-31 H340383 4/21/2017 2026-03-31 H340912 4/21/2017 2026-03-31 H341208 4/21/2017 2026-03-31 H342137 4/21/2017 2026-03-31 H341210 4/22/2017 2026-03-31 H343361 4/22/2017 2026-03-31 H343364 4/22/2017 2026-03-31 H343365 4/22/2017 2026-03-31 H297302 4/25/2017 2026-03-31 H340913 4/25/2017 2026-03-31 H341207 4/25/2017 2026-03-31 H341213 4/25/2017 2026-03-31 H342135 4/25/2017 202 |
|---|
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-0901-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.