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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