FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
- Recall number
- Z-1816-2013
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
- Status
- Open, Classified
- Initiated
- 2012-10-12
- Posted
- 2013-07-29
- Terminated
- not on file
- Reason
- It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.
- Root cause
- Packaging
- Action
- Synthes sent a Urgent Notice Medical Device Recall letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is requesting that you please examine your inventory for products with the above Part and Lot number and remove them. Call Synthes at 1-800-479-6329. If you have any further questions please call 610-719-5450.
- Quantity
- 8
- Distribution
- US Distribution including the states of CA, MN, NC and TN.
- Lot, serial or model codes
- Part Number 390.007, Lot Number 6800599
- 510(k) numbers
- ["K082650"]
- PMA numbers
- not on file
- Product code
- KTT
- 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