Z-2425-2015Class II

Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is...

Name: Z-2425-2015 Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is...
Creator: Synthes (USA) Products LLC
Published: 2015-07-01
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-07-01 / Terminated / root cause: sterility

FDA source

Synthes (USA) Products LLC began a recall of Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath... on 2015-07-01. FDA classified it as Class II and gives the reason as "The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2425-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-01
Posted: 2015-08-20
Terminated: 2016-08-18
Recalling firm: Synthes (USA) Products LLC
Product: Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital.
Product code: FSM Tray, Surgical, Instrument
Reason for recall: The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated July 8, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS REQUIRED We have on record that your facility has received the product(s) subject to this recall. DePuy Synthes asks that you review your inventory and immediately remove the affected lots from your stock. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 3 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, address, telephone number and signature in the spaces provided. Return the Verification Section (page 3 of this letter) with the product to Credit/Returns, DePuy Synthes, Send a copy of the completed Verification Section to DePuy Synthes by: Fax: 888-670-4162 or Scan/email: [email protected] Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. Return the documents to DePuy Synthes by: Fax: 888-670-4162 or Scan/email: [email protected] Note: If the Verification Section is answered on
Quantity in commerce: 1487
Distribution: Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand.
Product codes and lots: all lots of part numbers: 900.50, 900.51

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2425-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2425-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)