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ZMS INTRAMEDULLAR GUIDE WIRES (2015-08-31)
- Starting date:
- August 31, 2015
- Posting date:
- September 24, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55034
Affected Products
A. ZMS INTRAMEDULLAR SMOOTH GUIDE WIRE
B. ZMS INTRAMEDULLAR BULLET TIP GUIDE WIRE
C. M/DN INTRAMEDULLARY FIXATION GUIDE WIRE
D. PRESSURE SENTINEL INTRAMEDULLAR GUIDE WIRE
Reason
Zimmer Biomet is initiating a recall of guide wires labeled with a 10 year expiration date after it was found that while product labeling of these sterile guide wires (external carton label and patient record label) states a 10 year expiration date, package testing supports a 5 year expiration date.
Affected products
A. ZMS INTRAMEDULLAR SMOOTH GUIDE WIRE
Lot or serial number
>100 NUMBERS, CONTACT MFR
Model or catalog number
47-2237-033-00
47-2237-037-00
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
B. ZMS INTRAMEDULLAR BULLET TIP GUIDE WIRE
Lot or serial number
>100 NUMBERS, CONTACT MFR
Model or catalog number
47-2237-038-00
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
C. M/DN INTRAMEDULLARY FIXATION GUIDE WIRE
Lot or serial number
>100 NUMBERS, CONTACT MFR
Model or catalog number
00-2255-025-00
00-2255-026-00
47-2255-008-00
47-2255-008-01
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
D. PRESSURE SENTINEL INTRAMEDULLAR GUIDE WIRE
Lot or serial number
>100 NUMBERS, CONTACT MFR
Model or catalog number
00-2228-024-00