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U.S. Department of Health and Human Services

Class 2 Device Recall Ulnar Shortening Saw Blade

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 Class 2 Recall
Ulnar Shortening Saw Blade
see related information
Date Posted June 16, 2010
Recall Status1 Terminated on June 28, 2010
Recall Number Z-1807-2010
Recall Event ID 55410
Premarket Notification
510(K) Number
K012655 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones
Code Information Part Number: 80-0499-S Lot Numbers: 214436, 215637, 215638, 215639, 215640, 215641, 219931, and 220909.
Recalling Firm/
Manufacturer
Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro, Oregon 97124-9432
For Additional Information Contact Richard Snyder
888-627-9957
Manufacturer Reason
for Recall
The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action On April 14, 2010, Acumed began contacting consignees by telephone. On April 15, 2010, Acumed sent out the URGENT NOTICE: DEVICE RECALL Initial Notification letter and Recalled Product Status Form to their consignees. The letter describes the recall product as Ulnar Shorting Saw Blade-Hub Style S, Part no. 80-0499-S and Lot Codes. The Initial Notification letter instructs consignees to return the product back to Acumed immediately and notify their sub-accounts (customers) if products have been further distributed. The consignees also are asked to fill out and send back the Recalled Product Status Form . Customers should call the Customer Service at 1-888-627-9957 or e-mail to RecallNotification@acumed.net for any questions regarding the recall.
Quantity in Commerce 718 units
Distribution Worldwide distribution: USA and to the following countries: Spain, Great Britain, South Africa, Puerto Rico, Canada, Turkey, Ireland, Finland, Belgium, Australia, Germany, and Sweden.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = ACUMED, INC.
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