1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 recall: Labeling Error
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate…
Why was 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 recalled?
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog # 851.691.01S, Lot # 6123191, 6913455, 7540885
- Product
- 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 14 units
- Distribution
- Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)