FDA Device recall Z-0645-2022
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
- FDA Device
- Class II
- ongoing
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class II recall of Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110 by Howmedica Osteonics, citing there is a potential for the outer Tyvek lid to de-bond from the sealed package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0645-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-21 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Howmedica Osteonics |
| Distribution | PR |
Product
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
Reason
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
Identifiers
| code_info | UDI: 07613327013306; Lot Number: 87458602 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0645-2022%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.