Recall Z-1800-2015— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2015-05-13, terminated 2016-08-18. It names 2 FDA 510(k) clearances: K050683, K000684. Product: 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: Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly..
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-13
- Terminated
- 2016-08-18
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K050683 — SYNTHES (USA) 3.5MM CONICAL SCREWS
- K000684 — SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.