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Synthes XRL Medium Trial - Central Body, an instrument used… recallZ-1681-2014 · Synthes, Inc. · initiated Apr 8, 2014

Class II Terminated All recalls posted in June 2014

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, 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

Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1681-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 8, 2014
Posted by the FDA
Jun 2, 2014
Recalling firm
Synthes, Inc.
Quantity
3
Product code
MQP
FDA submissions
K103320
Distribution
US Distribution including the states of FL, NJ and MN.

Product description

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).

Code information (models, lots, serial numbers)

Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.

Other devices under the same FDA submission

9 devices cleared under K103320 — 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

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