The Recall Desk
LowFDA (Devices)·Z-0637-2017·Announced 2016-11-30

Synthes Recalls 2.5 mm Reaming Rods Due to Peel Pouch Delamination

Synthes (USA) Products LLC is recalling 1,951 sterile 2.5 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 specific defect is a packaging issue (peel pouch 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 1,951 units of the 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, 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 351.707S and specific lot numbers including 9963694 through 9963699, 9972862, and various H-series lot numbers. The products were distributed nationwide.

Healthcare providers and facilities should check their inventory for these specific catalog and lot numbers. If the product is found, it should be removed from use and returned to Synthes (USA) Products LLC according to the company's instructions.

The recalled product

Product
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
1,951

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 351.707S
  • Lot Numbers: 9963694
  • 9963695
  • 9963696
  • 9963697
  • 9963698
  • 9963699
  • 9972862
  • H040500
  • H040502
  • H040503
  • H060093
  • H060094
  • H060095
  • H060096
  • H060097
  • H080022
  • H080023
  • H080024
  • H080025

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 →

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