Z-0387-2014Class II

Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For...

Name: Z-0387-2014 Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For...
Creator: Synthes USA HQ, Inc.
Published: 2013-07-31
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-07-31 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of 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... on 2013-07-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0387-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-11-25
Terminated: 2015-06-01
Recalling firm: Synthes GmbH
Product: 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.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 135
Distribution: US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.
Product codes and lots: Part # Lot # SD357.371 5734551 6083065 6538811 6631975 6703191 6703190 6841538

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0387-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0387-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-25

Product code HSB

K011857Class IISynthes (USA) Trochanteric Fixation Nail (Tfn) SystemSynthes (Usa) / cleared 2001-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)