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K-Wire Systems (2016-10-31)
- Starting date:
- October 31, 2016
- Posting date:
- November 18, 2016
- 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-61162
Affected Products
- K-Wire - Sterile Single Use
- K-Wire, Recon, T2 Recon System
Reason
It was found through review of packaging that the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.
Affected products
A. K-Wire - Sterile Single Use
Lot or serial number
- K081727
- K08820B
- K089AF5
- K096A2C
- K09BA53
- K09BA55
Model or catalog number
- 1210-6450S
- 1806-0050S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY
B. K-Wire, Recon, T2 Recon System
Lot or serial number
- K086847
- K099AA8
Model or catalog number
- 1806-3030S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY