Synthes Recalls 4.5 mm LCP Proximal Tibia Plate Systems
Synthes (USA) Products LLC is voluntarily recalling 42 lots of 4.5 mm LCP Proximal Tibia Plate Systems due to a medical device defect.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes (USA) Products LLC is initiating a voluntary recall of 42 plate systems of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The recalled items include the Interlocking Bolt, which is a component of the surgical instrument system indicated for the treatment of nonunions, malunions, and fractures of the proximal tibia.
The recall covers specific lots identified by Lot Numbers 1776197 (5706588), 1782340, and 1868678, with Catalog ID 03.120.027. The products were distributed nationwide to 36 states, including Alabama, Arizona, California, Florida, New York, and Texas.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. The source text does not specify the exact nature of the defect or report any associated injuries or illnesses.
The recalled product
- Product
- Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Number# 1776197 (5706588)
- 1782340 and 1868678 Catalog ID 03.120.027 For lot 1776197
- the part is etched with 1776197
- the package label documents 5706588.
Distribution
Related recalls
Same manufacturer · Synthes (USA) Products LLC
See all →- HighVOLT locking screw taps swapped between lots carry incorrect thread
FDA (Devices) · 2026-04-08
- HighVOLT bone taps swapped between lots carry the incorrect thread
FDA (Devices) · 2026-04-08
- ModerateLocking bone screws recalled after packaging labeled with the wrong length
FDA (Devices) · 2025-10-29
- ModerateForty six millimetre locking screws recalled over wrong length on packaging
FDA (Devices) · 2025-10-29
- HighSurgical screwdrivers recalled for failure to engage with implant screws
FDA (Devices) · 2024-06-05
Same hazard · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22