OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Integra LifeSciences Corp. (NeuroSciences)
The hazard
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Product Code 3032Model UDI 10381780268468Model Product Code 3055Model UDI 10381780268505Model Product Code 3069Model UDI 10381780268512Model Product Code 3076Model UDI 10381780268529Model Product Code 3086Model UDI 10381780268536Model Product Code 3092Model UDI 10381780268550Model Product Code 3093Model UDI 10381780268567Model Product Code 3096Model UDI 10381780268581Model Product Code 3098Model UDI 10381780268598Model Product Code 3099Model UDI 10381780268604Model Product Code 3133Model UDI 10381780268680Model Product Code 3137Model UDI 10381780268697Model Product Code 3142UPC 10381780268468UPC 10381780268505UPC 10381780268512UPC 10381780268529UPC 10381780268536UPC 10381780268550UPC 10381780268567UPC 10381780268581UPC 10381780268598UPC 10381780268604UPC 10381780268680UPC 10381780268697UPC 10381780268710UPC 10381780268734UPC 10381780268758UPC 10381780268826UPC 10381780268833UPC 10381780268857UPC 10381780268871UPC 10381780268888UPC 10381780268895UPC 10381780268901UPC 10381780268918UPC 10381780268925UPC 10381780268932Would you have heard about this one?
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