Z-0092-2015Class II

DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

Name: Z-0092-2015 DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Creator: Synthes, Inc.
Published: 2014-10-02
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-10-02 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715 on 2014-10-02. FDA classified it as Class II and gives the reason as "Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a...". 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-0092-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-02
Posted: 2014-10-20
Terminated: 2015-12-18
Recalling firm: Synthes GmbH
Product: DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Product code: GAD Retractor
Reason for recall: Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated October 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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. Send a copy of the completed Verification Section to DePuy Synthes by: Fax: (610) 430-7083 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: (610) 430-7083 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 have any questions, please call 610-719-5450, or contact your DePuy Synthes sales consultant. Thank you for your attention to this issue.
Quantity in commerce: 11
Distribution: US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.
Product codes and lots: Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0092-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0092-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20

Product code GAD

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)