PlainRecalls
FDA Devices Moderate Class II Terminated

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

Reported: November 4, 2015 Initiated: October 6, 2015 #Z-0167-2016

Product Description

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

Reason for Recall

Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

Details

Units Affected
98
Distribution
US Distribution to the state of : TN
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.. Recalled by Synthes (USA) Products LLC. Units affected: 98.
Why was this product recalled?
Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 4, 2015. Severity: Moderate. Recall number: Z-0167-2016.