M/DN Intramedullary Fixation Humeral Guide Wire - Smooth, ZMS Intramedullary Fixation Smooth Guide Wire, Zimmer Natural Nail System - Tear Drop Guide Wire, and Pressure Sentinel Intramedullary Reaming System, Guide Wire (2018-10-30)
- Starting date:
- October 30, 2018
- Posting date:
- November 28, 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-68386
Affected products
- M/DN Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length or Bullet Tip, 2.4 mm Diameter, 70 cm Length
- ZMS Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm or 3.0 mm Diameter or Bullet Tip, 3.0 mm Diameter
- M/DN Intramedullary Fixation Humeral Guide Wire or Humeral Guide Wire or Smooth Guide Wire
- Zimmer Natural Nail System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length or 70 cm Length or 2.4 mm Diameter
- Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter
Reason
Zimmer Biomet is conducting a medical device recall for various trauma guide wires due to potential creases in the sealing area on the end opposite of the product's chevron opening.
Affected products
A. M/DN Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length or Bullet Tip, 2.4 mm Diameter, 70 cm Length
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, 2.4 mm Diameter, 100 cm or 3.0 mm Diameter or Bullet Tip, 3.0 mm Diameter
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- 47-2237-033-00
- 47-2237-037-00
- 47-2237-038-00
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
C. M/DN Intramedullary Fixation Humeral Guide Wire or Humeral Guide Wire or Smooth 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
D. Zimmer Natural Nail System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length or 70 cm Length or 2.4 mm Diameter
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- 47-2490-097-00
- 47-2490-098-00
- 47-2490-098-01
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
E. Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 00-2228-024-00
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES