The Recall Desk
HighFDA (Devices)·Z-1057-2014·Announced 2014-02-26

Synthes Driving Cap/Threaded Recalled for Binding in Insertion Handles

Synthes, Inc. is recalling 143 units of the Driving Cap/Threaded because the parts can bind in insertion handles, making them difficult to separate.

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. The hazard involves a mechanical defect (binding) in a medical device that could impede the surgical procedure, representing a risk of harm without reported fatalities or serious injuries.

Plain-English summary

Synthes, Inc. is recalling 143 units of the Synthes Driving Cap/Threaded. These parts are intended for use in the Tibia system, LFN and RAFN systems to insert a nail. The recall is due to a defect where the Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled, becoming difficult to separate.

The affected products are identified by Part No. 03.010.523 and Lot Nos. 8279162 & 8429004. The recall covers nationwide distribution in the USA. The FDA has classified this recall as Class II.

Healthcare providers and facilities should stop using the affected parts and contact Synthes, Inc. for instructions on how to return or replace the products.

The recalled product

Product
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be insert
Manufacturer
Synthes, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
143

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 (2)

  • Part No. 03.010.523
  • Lot Nos. 8279162 & 8429004

Distribution

Distributed nationwide across the United States.

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