Z-0885-2016 Class II Terminated
FDA device recall Z-0885-2016 was initiated by Biomet, Inc. on Feb 16, 2016 and is designated Class II. Reason for recall: A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing… The recall status is terminated (terminated Feb 14, 2017). Affected quantity: 23 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2016
- Initiation Date
- Feb 16, 2016
- Termination Date
- Feb 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units
Product Description
HipLOC CHS Plate/Lag Screw Introducer
Reason for Recall
A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.
Distribution Pattern
US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.
Code Information
Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0885-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026