Z-0669-2018 Class II Terminated
FDA device recall Z-0669-2018 was initiated by Synthes, Inc. on August 7, 2017 and is designated Class II. Reason for recall: May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the dr… The recall status is terminated (terminated July 25, 2018). Affected quantity: 567 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- August 7, 2017
- Termination Date
- July 25, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 567 units
Product Description
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Reason for Recall
May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
Distribution Pattern
Distribution to US, Canada, and Germany.
Code Information
Lot numbers FT00227 9972971 H028400 H161606 H288454