Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- July 31, 2013
- Posted
- November 25, 2013
- Terminated
- June 1, 2015
- Recall Number
- Z-0387-2014
- Quantity
- 135
- Firm Location
- West Chester, PA
Reason for Recall
The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.
Distribution
US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.
Lot / Code Info
Part # Lot # SD357.371 5734551 6083065 6538811 6631975 6703191 6703190 6841538
Root Cause
Process control
Action Taken
Synthes sent an Urgent Notice: Medical Device Recall letter dated July 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken: Our records indicate you received this product. Synthesis requesting that the product be returned: If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. "Return the Verification Form {page 3 of this letter) with the product to: "Credit/Returns, Synthes, .1101 Synthes Avenue, Monument, CO 80132. If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. "Return the documents to Synthes by. " Fax: 1-888-731-7952 or " Scan/email: FieldAction@synthes.com If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue