Stryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
Stryker Howmedica Osteonics Corp. is recalling specific lots of GAM Kirschner Wires and T2 K-Wires because a manufacturing error may have compromised the sterile pouch seal.
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 source text describes a potential packaging defect without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 2,084 units of GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R, and T2 K-Wire Recon. These medical devices are intended for the temporary stabilization of bone segments or fragments. The recall covers specific manufacturing part numbers and lot numbers distributed nationwide in the US and internationally to Australia, Canada, Chile, Switzerland, Spain, France, Great Britain, Sweden, Japan, South Africa, and the Netherlands.
The recall was initiated after a review of packaging revealed that the seal integrity of the pouch may be compromised. Specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error. This defect could affect the sterility of the device.
Healthcare providers and facilities that have received these specific lots should stop using the affected products and contact Stryker Howmedica Osteonics Corp. for further instructions on how to return or dispose of the units.
The recalled product
- Product
- GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 2,084
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)
- GAM Kirschner Wire - Manufacturing Part Number 12106450S
- Lot #'s K0800BB
- K0800BC
- K0800BD
- K0800BE
- K0800BF
- K0800C0
- K081720
- K081721
- K0810872
- K081723
- K081727
- K082C8B
- K084F89
- K084F98
- K08683D
- K08683E
- K086841
- K08820B
- K089AF5
Distribution
Distributed nationwide across the United States.
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