FDA Device recall Z-0973-2019
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue a…
- FDA Device
- Class II
- terminated
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class II recall of Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue a… by Stryker Sustainability Solutions, citing affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0973-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-27 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
Product
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
Reason
Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.
Identifiers
| code_info | Catalog Numbers: 375-450-000 375-940-000, 375-532-000 375-940-012, 375-534-000 375-941-000, 375-542-000 375-941-012, 3…Catalog Numbers: 375-450-000 375-940-000, 375-532-000 375-940-012, 375-534-000 375-941-000, 375-542-000 375-941-012, 375-544-000 375-941-500, 375-545-000 375-950-000, 375-548-000 375-950-012, 375-552-000 375-950-112, 375-554-000 375-951-000, 375-555-000 375-951-012, 375-562-000 375-951-100, 375-564-000 375-951-112, 375-565-000 375-951-200 and 375-747-000 375-952-000. Lots from affected catalog numbers: 4601435 7687551 7954336 8069955 8143951 8213505 8290940 4866597 7692818 7957638 8078776 8143979 8216233 8296920 5275122 7695149 7962443 8078965 8144105 8220563 8297887 5810401 7696653 7964118 8079076 8144770 8220748 8297970 6165680 7702505 7964966 8082376 8146583 8223629 8298035 6552450 7725942 7965089 8082638 8148337 8223910 8298128 6563177 7743624 7969196 8082746 8150492 8224388 8298625 6634381 7755555 7978089 8095770 8150617 8224621 8305181 6694100 7766506 7978931 8096123 8150664 8228215 8305467 6705350 7767267 7981959 8096255 8152993 8228340 8305524 6712065 7768175 79 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0973-2019%22
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