FDA Device recall Z-0635-2022
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic s…
- FDA Device
- Class II
- ongoing
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic s… by Smith And Nephew, citing products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0635-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-14 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Reason
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Identifiers
| code_info | Lot Numbers: 50971615, 50971617 & 50967788 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0635-2022%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.