Z-0439-2018 Class II Terminated
FDA device recall Z-0439-2018 was initiated by Zimmer Biomet, Inc. on Aug 7, 2017 and is designated Class II. Reason for recall: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed… The recall status is terminated (terminated Mar 29, 2019). Affected quantity: 638 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 7, 2018
- Initiation Date
- Aug 7, 2017
- Termination Date
- Mar 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 638 units
Product Description
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
Reason for Recall
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Distribution Pattern
US nationwide distribution. Also Portugal and the Netherlands.
Code Information
Item No. 814611460; Lot No. (Exp. Date) UDI: 555810 (05/27/2027) UDI (01)00887868039867 (17)270527 (10)555810; 788580 (07/17/2027) UDI (01)00887868039867 (17)270717 (10)788580
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0439-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026