Z-0161-2012

Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal...

Name: Z-0161-2012 Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal...
Creator: Synthes USA (HQ), Inc.
Published: 2011-09-23
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2011-09-23 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA (HQ), Inc. began a recall of Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes... on 2011-09-23. The reason FDA records is "LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0161-2012
Status: Terminated
Initiated: 2011-09-23
Posted: 2011-11-04
Terminated: 2014-12-18
Recalling firm: Synthes GmbH
Product: Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: SYNTHES sent an URGENT MEDICAL DEVICE LABELING CORRECTION letter dated September 23, 2011, to all affected customers. The labeling has been revised. Updated information packets have been sent to all accounts which included the final labeling and communications to accounts and sales force. Customers were instructed to review the updated supplemental labeling provided in the package Customers were instructed to attach the supplementary technique page to an T-PAL Spacer Brochure that may be in their facility. They can access an electronic version of the Brochure by accesssng Product Literature at the following link: http://us.synthes.com. The new version can be identified by code J10120 located at the bottom right corner of the back cover. To confirm receipt and understanding of the information, customers were requested to complete the Verification Section of the letter and return it to Synthes by either of the following methods: Mail provided postage paid envelope Fax 610-251-9005 Scan/e-mail to [email protected] For any questions call 1-800-420-7025 x5403 or contact their Synthes Spine Sales Consultant.
Quantity in commerce: N/A - Labeling Correction
Distribution: Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, HI, KS, KY, LA, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. and Puerto Rico and Washington, D.C; Internationally to Canada and Japan
Product codes and lots: Part number 01.812.001 - T-PAL Instrument and Implant Set

Product code MAX

K100089Class IISynthes T-Pal SpacerSynthes Spine / cleared 2010-05-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)