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U.S. Department of Health and Human Services

Class 2 Device Recall CREAMER

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  Class 2 Device Recall CREAMER see related information
Date Initiated by Firm January 28, 2010
Date Posted August 24, 2010
Recall Status1 Terminated 3 on December 15, 2010
Recall Number Z-2252-2010
Recall Event ID 54701
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH

REF 8772A, 9.0MM, QTY DIST 712.
REF 8773A, 10MM, QTY DIST 1,244.
REF 8774A, 11MM, QTY DIST 384
REF 8775A, 12MM, QTY DIST 156

Code Information Lot Number: REF 8772A - 46688,  73871,  73870,  73869,  87154,  86536,  87153,  86537,  98292,  98291,  111143,  111144,  112911,  112912,  116059.   REF 8773A - 65279,  65280,  65278,  83399,  83400,  88699,  88698,  101187,  98663,  101186,  112011,  113322,  121931.   REF 8774A - 65265,  65264,  65266,  87162,  91944,  102320,  101157,  113329.   REF 8775A - 46684,  73851,  73852,  91942,  96125,  96126,  101183, and  102325.         
Recalling Firm/
Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Roger Murphy
Manufacturer Reason
for Recall
This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents.
FDA Determined
Cause 2
Material/Component Contamination
Action Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.
Quantity in Commerce 35,451 total
Distribution Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.