Synthes Recalls 1.5 mm Rapid Resorbable Orbital Floor Plates Due to Labeling Errors
Synthes (USA) Products LLC is recalling 14 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding expiration dates, which fits the rubric criteria for Moderate severity.
Plain-English summary
Synthes (USA) Products LLC is recalling 14 units of the 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. The product is a sterile, rapid resorbable fixation system intended for fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
The recall was initiated due to labeling errors where the expiration date on the outer package label may exceed the expiration date of the subcomponents. The affected units are identified by Catalog # 851.691.01S and Lot # 6123191, 6913455, or 7540885.
The products were distributed nationwide to facilities in Delaware, North Carolina, California, Oklahoma, Pennsylvania, South Carolina, Wisconsin, Colorado, New Jersey, Texas, Utah, Illinois, Missouri, Michigan, Alabama, and Kansas. Healthcare providers should stop using the affected units and contact Synthes (USA) Products LLC for further instructions.
The recalled product
- 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 with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog # 851.691.01S
- Lot # 6123191
- 6913455
- 7540885
Distribution
Part of a larger recall action
This product is one of 3 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Synthes (USA) Products LLC
See all →- HighVOLT locking screw taps swapped between lots carry incorrect thread
FDA (Devices) · 2026-04-08
- HighVOLT bone taps swapped between lots carry the incorrect thread
FDA (Devices) · 2026-04-08
- ModerateLocking bone screws recalled after packaging labeled with the wrong length
FDA (Devices) · 2025-10-29
- ModerateForty six millimetre locking screws recalled over wrong length on packaging
FDA (Devices) · 2025-10-29
- HighSurgical screwdrivers recalled for failure to engage with implant screws
FDA (Devices) · 2024-06-05
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSynthes 4.5 mm LCP Curved Condylar Plate Recalled for Mislabeling
FDA (Devices) · 2013-12-04
- LowSynthes Recalls Six LCP Dia-Meta Volar Distal Radius Plates Due to Packaging Error
FDA (Devices) · 2016-06-22
- HighSynthes 2.4 mm LC-DCP Plate Recalled Due to Foreign Object
FDA (Devices) · 2013-12-04
- HighSynthes Recalls 4.5 mm LCP Proximal Tibia Plate Systems
FDA (Devices) · 2016-04-06
- ModerateSynthes Humerus Plates Recalled for Incorrect Part Number Labeling
FDA (Devices) · 2015-10-21
- ModerateSynthes Ti Button Plate Recalled for Inaccurate MR Safety Labeling
FDA (Devices) · 2016-07-13