Z-1681-2014Class II

Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral...

Name: Z-1681-2014 Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral...
Creator: Synthes, Inc.
Published: 2014-04-08
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-04-08 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The... on 2014-04-08. FDA classified it as Class II and gives the reason as "Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height". 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-1681-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-08
Posted: 2014-06-02
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated April 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action Required: Synthes has record that your facility has the product(s) subject to this recall. Synthes asks that you review your inventory and immediately remove the affected lots from stock. If you DO have any of the identified devices, please take the following steps: Contact your local Synthes Spine Sales Consultant to return any inventory located within your facility. 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. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Form (page 4 of this letter) to: Fax: 877-270-9246 or Scan/email: [email protected] 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: 877-270-9246 or Scan/email: [email protected] Note: If the Verification Form 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 4 of the notification. If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant.
Quantity in commerce: 3
Distribution: US Distribution including the states of FL, NJ and MN.
Product codes and lots: Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1681-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1681-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

Product code MQP

K103320Class IISynthes XrlSynthes Spine Co.Lp / cleared 2011-10-20

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)