Z-1837-2014 Class II Terminated
FDA device recall Z-1837-2014 was initiated by Biomet, Inc. on May 7, 2014 and is designated Class II. Reason for recall: Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. The recall status is terminated (terminated Oct 30, 2015). Affected quantity: 1047 total.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 25, 2014
- Initiation Date
- May 7, 2014
- Termination Date
- Oct 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1047 total
Product Description
G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
Reason for Recall
Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.
Code Information
PN:110003458. Lots 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304 and ZB140201.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1837-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026