The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0362-2016·Announced 2015-12-09

Stryker Duracon Tibial Wedge Implants Recalled for Packaging Integrity Issues

Stryker is recalling 2,577 Duracon Tibial Wedge implants because they punctured the packaging's Tyvek lids, potentially compromising sterility.

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 potential breach of sterile packaging without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling 2,577 units of Duracon Flat Tibial Wedge Cemented use only Sterile implants. These tibial wedges are components of the Total Stabilizer Knee system, intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.

The recall was initiated after Stryker received two customer complaints indicating that the Duracon Tibial Wedge implants had punctured the Tyvek lids of their packaging. This defect raises concerns about the integrity of the sterile barrier system.

The affected products were distributed nationwide in the United States as well as in Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, the Netherlands, Poland, Romania, Spain, Sweden, and Switzerland. The recall covers multiple lot numbers and specific catalog numbers ranging from 6630-6-105 to 6630-6-475. Healthcare providers and patients should contact Stryker for further instructions on handling these specific units.

The recalled product

Product
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended…
Manufacturer
Stryker Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
2,577

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)

  • Multiple Lot Numbers. Catalog Numbers: 6630-6-105
  • 6630-6-110
  • 6630-6-125
  • 6630-6-130
  • 6630-6-150
  • 6630-6-155
  • 6630-6-170
  • 6630-6-175
  • 6630-6-205
  • 6630-6-210
  • 6630-6-225
  • 6630-6-230
  • 6630-6-250
  • 6630-6-255
  • 6630-6-270
  • 6630-6-275
  • 6630-6-305
  • 6630-6-310
  • 6630-6-325
  • 6630-6-330

Distribution

Distributed nationwide across the United States.

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