1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
Reported: June 15, 2016 Initiated: May 2, 2016 #Z-1919-2016
Product Description
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
Reason for Recall
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 19 units
- Distribution
- Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.. Recalled by Synthes (USA) Products LLC. Units affected: 19 units.
Why was this product recalled? ▼
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1919-2016.
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