Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
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. The hazard is a potential decrease in packaging seal integrity, which is a precautionary measure to ensure sterility, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling Stryker Gamma K-Wires (3.2x450 mm) intended for the temporary stabilization of bone segments or fragments. The recall was initiated after a review of the packaging determined that the seal integrity of the pouch may be decreased.
The recall affects 147,838 units in total, which were distributed nationwide in the US. The affected products have catalog number 12106450S and include all lots distributed before November 10, 2015, with a non-expired 5-year shelf life.
Healthcare providers and facilities should stop using the affected K-Wires and contact Stryker Howmedica Osteonics Corp. for further instructions on the recall.
The recalled product
- Product
- Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 147,838
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 (2)
- Catalog number 12106450S
- All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Stryker Howmedica Osteonics Corp. 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 18 products in this recall →Related recalls
Same manufacturer · Stryker Howmedica Osteonics Corp.
See all →- HighStryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
FDA (Devices) · 2017-05-31
- SevereStryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
FDA (Devices) · 2017-01-18
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighStryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19
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
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- HighStryker Gamma3 End Cap Recalled Due to Compromised Sterility
FDA (Devices) · 2020-06-24
- ModerateStryker Restoration Anatomic Shell Recall Due to Packaging Defect
FDA (Devices) · 2020-05-27
- HighStryker Restoration Anatomic Shell Recalled Due to Packaging Defect
FDA (Devices) · 2020-05-27
- HighStryker Restoration Anatomic Shell Recalled for Packaging Defect
FDA (Devices) · 2020-05-27
- HighStryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity
FDA (Devices) · 2020-06-24