Various Guide Wire products from Zimmer Inc. (2018-04-05)
- Starting date:
- April 5, 2018
- Posting date:
- April 24, 2018
- 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-66564
Affected products
- M/DN Intramedullary Fixation System
- ZMS Intramedullary Fixation Smooth Guide Wire
- ZMS Intramedullary Fixation Smooth Guide Wire With Bullet Tip
- M/DN Intramedullary Fixation Humeral Guide Wire
- Zimmer Natural Nail System Tear Drop Guide Wire
- Pressure Sentinel Intramedullary Reaming System Guide Wire
Reason
Zimmer Biomet is conducting a lot specific medical device recall for various sterile packaged trauma guide wires due to process monitoring failures related to the sterile seal on the packaging. A breach in the packaging seal could potentially lead to loss of sterility of the device.
Affected products
A. M/DN Intramedullary Fixation System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 00-2255-025-00
- 00-2255-026-00
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
B. ZMS Intramedullary Fixation Smooth Guide Wire
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
47-2237-033-00
47-2237-037-00
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
C. ZMS Intramedullary Fixation Smooth Guide Wire With Bullet Tip
Lot or serial number
63645655
63650115
63650116
63655995
63655996
63655997
63655998
Model or catalog number
47-2237-038-00
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
D. M/DN Intramedullary Fixation Humeral Guide Wire
Lot or serial number
More than 100 numbers, contact manufacturer.
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
E. Zimmer Natural Nail System Tear Drop Guide Wire
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
47-2490-097-00
47-2490-097-01
47-2490-098-00
47-2490-098-01
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
F. Pressure Sentinel Intramedullary Reaming System Guide Wire
Lot or serial number
63655999
63715685
63731170
63733045
63812299
Model or catalog number
00-2228-024-00
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES