Reported Apr 24, 2013 · Terminated
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured…
Synvasive Technology Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synvasive Technology Inc · 4925 Robert J Mathews Pkwy · El Dorado Hills, CA · 95762-5701
Is this the product you have?
- 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 bladeA sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement
- Lot codes and dates
- Lots Numbers included in Recall
1X311012511632515023150241Y224233260X401263851Y174171510Y280171502202828114190712337223346235042350525134253412W2232X105260012W5732W5742434825304253332606826165270152701629392PD4647
- Lots Numbers included in Recall
- Amount recalled
- 3442 units per the part numbers listed
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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