Z-0931-2009

Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR...

Name: Z-0931-2009 Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR...
Creator: Synthes Spine
Published: 2008-11-20
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2008-11-20 / Terminated / root cause: design

FDA source

Synthes Spine began a recall of Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR is indicated for use in patients with degenerative... on 2008-11-20. The reason FDA records is "screwdriver tip may break off and lodge in the screw head". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0931-2009
Status: Terminated
Initiated: 2008-11-20
Posted: 2009-01-30
Terminated: 2009-10-27
Recalling firm: Synthes GmbH
Product: Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: screwdriver tip may break off and lodge in the screw head
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm emailed all Spine Sales Consultants on 11/20/08. They were instructed to immediately examine their stock and discuss appropriate technique with surgeon users. In addition, a Medical Device Correction letter dated 11/19/08 was issued via USPS certified mail to the medical facilities. This initial letter stated the issue and requested the users take the following actions: discard all SynFix Technique Guides and replace with the updated literature contained in the mailing packet with the letter, and is identified by code J7022-E (Rev. E); to ensure receipt and understanding of the information, the Verification Section of the letter needs to be completed and returned to Synthes by either fax: 610-719-5120 or scan/e-mail: [email protected]. An Urgent: Medical Device Recall letter, dated 1/16/2009, was also sent out. This latter letter requested that users examine their stock immediately and remove any of the affected devices from their inventory. Customers are also to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the Verification Section; and return the letter with the recalled product to the address listed. There are also actions for those who do not have the affected product. Questions should be directed to 800-620-7025 x 5453 or 610-719-5453.
Quantity in commerce: 381 units
Distribution: Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA ,SC, TN, TX, UT, VA, WA, and WI, and countries of Canada and Switzerland.
Product codes and lots: Lot numbers: 2317363, 2331806, 2331810, 2387975, 2387976, 2401982, 5637286, 5644605, 5660377, 5664629, 5826243, and 5826244.

Product code MAX

K072253Class IISynfix-Lr SpacerSynthes Spine Co.Lp / cleared 2007-10-12

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)