Z-1838-2014 Class II Terminated
FDA device recall Z-1838-2014 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 Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
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: 110003500. Lots 469610, ZB130701, ZB130702, ZB130703, ZB130901, ZB131001, ZB131002, 881430, ZB131101, ZB140101, and 360877.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1838-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026