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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann Palatal Implant

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 Class 2 Device Recall Straumann Palatal Implantsee related information
Date Initiated by FirmSeptember 28, 2007
Date PostedDecember 04, 2007
Recall Status1 Terminated 3 on April 16, 2010
Recall NumberZ-0278-2008
Recall Event ID 45420
510(K)NumberK060062 
Product Classification Endosseous Orthodontic Implant - Product Code OAT
ProductStraumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
Code Information Lot Number: 1001
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactSame
800-448-8168
Manufacturer Reason
for Recall		Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
FDA Determined
Cause 2		Device Design
ActionStraumann USA, LLC sent Urgent Device Recall letters, via FedFx on 9/28/07, requesting the return of all Straumann Palatal Implant, articles 042.335 with lot numbers 1001, FE3776, F4662, F6563, E7083, and article 042.336S lot number 1001.
Quantity in Commerce32 units
DistributionNationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and WA.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = OAT
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