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
This recall has been terminated (originally issued June 16, 2010).
- Company
- Acumed Llc
- Recall Initiated
- April 14, 2010
- Posted
- June 16, 2010
- Terminated
- June 28, 2010
- Recall Number
- Z-1807-2010
- Quantity
- 718 units
- Firm Location
- Hillsboro, OR
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Part Number: 80-0499-S Lot Numbers: 214436, 215637, 215638, 215639, 215640, 215641, 219931, and 220909.
Root Cause
Other
Action Taken
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.