Recall Z-1115-2013— Synvasive Technology Inc
Class II · Terminated
Class II FDA medical device recall by Synvasive Technology Inc, initiated 2013-04-02, terminated 2014-07-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.. Reason: Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System..
- Recalling firm
- Synvasive Technology Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-02
- Terminated
- 2014-07-15
- Firm location
- El Dorado Hills, CA, United States
Product description
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
Reason for recall
Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
Data sourced from openFDA. This site is unofficial and independent of the FDA.