EasyFuse Dynamic Compression System Instrument Pack
FDA Recall Z-0853-2022 · Posted None
Advertisement
Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeJDR
Date Initiated2022-03-10
Date Terminated2026-04-01
Product Quantity176 packs
Reason for Recall
The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
Firm Action
A recall notice was disseminated to the distributor and sales representatives via email (09-Mar-2022 and 10-Mar-2022) and to the hospitals via mail (10-Mar-2022, FedEx Priority Overnight). The hospital letters were delivered on 11-Mar-2022. Customers were instructed to immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility and remove them from their point of use. They are to return the enclosed business reply form by email to confirm receipt of the notification/document product segregation. Upon receipt of the completed business reply form, Stryker will arrange for the return and replacement of the product(s). Effectiveness checks will be performed through the confirmation of the returned/signed acknowledgement form.
Root Cause
Device Design
Distribution Pattern
US distribution to Florida, North Carolina, Ohio, and Texas
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement