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Large Buttress Compression Nut For Blade Guide Sleeve TFN recallZ-0387-2014 · Synthes USA HQ, Inc. · initiated Jul 31, 2013

Class II Terminated All recalls posted in November 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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: [email protected] If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue

Recall details

Recall number
Z-0387-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 31, 2013
Posted by the FDA
Nov 25, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
135
Product code
HSB
FDA submissions
K011857
Distribution
US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.

Product description

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.

Code information (models, lots, serial numbers)

Part # Lot #    SD357.371 5734551   6083065   6538811   6631975   6703191   6703190   6841538

Other devices under the same FDA submission

44 devices cleared under K011857 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page