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Soft Tissue Retractor (August 07, 2013)
- Starting date:
- August 07, 2013
- Posting date:
- August 07, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-35441
Reason
Synthes (Canada) Ltd. Is initiating a voluntary labelling recall related to the surgical technique guide, "plate insertion instruments. For minimally invasive plate ostemynthesis (MIPO)." This action has been initiated as a result of review for the previous recall of the soft tissue retractor, small, extendible (325.010) due to locking nut (clamping sleeve) malfunction. The revised surgical technique guides contains a precaution on page 3 stating "do not overtighten the clamping sleeve as this could lead to breakage".
This labelling recall requires that customers review the new technique guides provided in this mailing and replace previous revisions with the revised copies.
Affected products
Soft Tissue Retractor (2013-08-07)
Lot or serial number
Not applicable
Model or catalog number
325.010
Companies
- Manufacturer
- Not Applicable
- Date modified: