PlainRecalls
FDA Devices Moderate Class II Terminated

3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.

Reported: June 24, 2015 Initiated: May 13, 2015 #Z-1800-2015

Product Description

3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.

Reason for Recall

Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

Details

Recalling Firm
Synthes, Inc.
Units Affected
54
Distribution
Nationwide Distribution
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.. Recalled by Synthes, Inc.. Units affected: 54.
Why was this product recalled?
Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 24, 2015. Severity: Moderate. Recall number: Z-1800-2015.