Synthes Recalls 3.0 mm Reaming Rods Due to Pouch Delamination
Synthes (USA) Products LLC is recalling 5,478 sterile 3.0 mm reaming rods because their peel pouches are delaminating.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the defect is limited to packaging delamination with no reported injuries or illnesses, fitting the criteria for a low-severity packaging-only problem.
Plain-English summary
Synthes (USA) Products LLC is recalling 5,478 units of the 3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile. The recall is due to a defect in the packaging where the peel pouches for the affected reaming rods and extraction hooks are delaminating.
The affected products are identified by Catalog ID 351.76S and specific lot numbers listed in the recall documentation. The products were distributed nationwide.
Healthcare facilities should stop using the affected products and contact Synthes (USA) Products LLC for further instructions on the recall.
The recalled product
- Product
- 3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 5,478
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 (20)
- Catalog ID 351.76S
- Lot Numbers: 9938361
- 9970591
- H000103
- H001021
- H032765
- H032769
- H033313
- H043056
- H043057
- H043058
- H043551
- H043564
- H054931
- H054932
- H054933
- H056192
- H056193
- H056194
- H058374
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.
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