Synthes Recalls 2.5 mm Calibrated Reaming Rods Due to Pouch Delamination
Synthes (USA) Products LLC is recalling 260 sterile 2.5 mm TI Calibrated Reaming Rods because their peel pouches are delaminating.
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 the hazard involves a packaging defect (delamination) that poses a theoretical risk to sterility, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Synthes (USA) Products LLC is recalling 260 units of the 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile. The affected products are identified by Catalog ID 359.083S and Lot Numbers H115566, H116597, H116601, and H117049. These items were distributed nationwide.
The recall was initiated because the peel pouches for the affected reaming rods and extraction hooks are delaminating. This defect may compromise the sterile barrier of the packaging.
Healthcare facilities and consumers should stop using these specific products and contact Synthes (USA) Products LLC for further instructions or a replacement.
The recalled product
- Product
- 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 260
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 (5)
- Catalog ID 359.083S
- Lot Numbers: H115566
- H116597
- H116601
- H117049
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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 8 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 · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighSynthes Recalls 2.5 mm Titanium Calibrated Reaming Rods Due to Sterility Concerns
FDA (Devices) · 2018-03-14
- HighSynthes Recalls 2.5 mm Reaming Rods Due to Potential Sterility Loss
FDA (Devices) · 2018-03-14
- HighSynthes Reaming Rods Recalled for Potential Sterility Seal Defects
FDA (Devices) · 2018-03-14
- HighSynthes 2.5 mm Guide Rods Recalled for Potential Sterility Loss
FDA (Devices) · 2018-03-14
- HighSynthes Recalls Sterile Light Clip for Oracle Retractor Due to Potential Lack of Sterility
FDA (Devices) · 2018-03-14
- ModerateSynthes Recalls Spinal Pedicle Fixation Rods Due to Finishing Process Error
FDA (Devices) · 2015-10-28