Recall Z-0938-2013— Synthes USA HQ, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-01-11, terminated 2015-09-10. It names one FDA 510(k) clearance: K992739. Product: Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.. Reason: Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm..
- Recalling firm
- Synthes USA HQ, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-11
- Terminated
- 2015-09-10
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Reason for recall
Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
Data sourced from openFDA. This site is unofficial and independent of the FDA.