Synthes USA (HQ), Inc.: 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.

Recall number

Z-0161-2012

Recalling firm

Synthes USA (HQ), Inc.

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.

Status

Terminated

Initiated

2011-09-23

Posted

2011-11-04

Terminated

2014-12-18

Reason

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

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 FieldAction@synthes.com For any questions call 1-800-420-7025 x5403 or contact their Synthes Spine Sales Consultant.

Quantity

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

Lot, serial or model codes

Part number 01.812.001 - T-PAL Instrument and Implant Set

510(k) numbers

["K100089"]

PMA numbers

not on file

Product code

MAX

Firm FEI

3005180112

Firm city

West Chester

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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