FDA Medical Device Recalls (openFDA)
Synthes USA (HQ), Inc.: SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.
- Recall number
- Z-2583-2010
- Recalling firm
- Synthes USA (HQ), Inc.
- Product
- SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.
- Status
- Terminated
- Initiated
- 2010-07-23
- Posted
- not on file
- Terminated
- 2014-12-18
- Reason
- A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient.
- Root cause
- Error in labeling
- Action
- Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: FieldAction@Synthes.com. If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant.
- Quantity
- not on file
- Distribution
- Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore.
- Lot, serial or model codes
- Catolog Number: 03.802.039 - all lot numbers
- 510(k) numbers
- ["K053508"]
- PMA numbers
- not on file
- Product code
- MQP
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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