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BIOMET HIP SYSTEM MODULAR HEAD COMPONENT -6MM NECK, 36MM TYPE 1 TAPER (2017-09-27)
- Starting date:
- September 27, 2017
- Posting date:
- October 6, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, Healthcare Professionals, General Public
- Identification number:
- RA-64784
Affected products
BIOMET HIP SYSTEM MODULAR HEAD COMPONENT -6MM NECK, 36MM TYPE 1 TAPER
Reason
Zimmer Biomet is conducting a medical device recall for a single lot of the Biomet Hip System modular head component -6mm neck, 36mm type 1 taper. One piece from a different lot mixed with lot 236840 and is incorrectly etched as - 6mm offset instead of +3mm offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
Affected products
BIOMET HIP SYSTEM MODULAR HEAD COMPONENT -6MM NECK, 36MM TYPE 1 TAPER
Lot or serial number
LOT 236840
Model or catalog number
11-363660
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive
Warsaw
46581
Indiana
UNITED STATES