Recall Z-1833-2014— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2014-04-10, terminated 2016-08-26. It names 5 FDA 510(k) clearances: K122455, K092190, K090658 and 2 more. Product: Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.. Reason: Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe..
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-10
- Terminated
- 2016-08-26
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K122455 — SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
- K092190 — SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
- K090658 — SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
- K082650 — SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
- K030390 — SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Reason for recall
Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
Data sourced from openFDA. This site is unofficial and independent of the FDA.