Stryker T2 Tibia Nail Insertion Sleeve Recall Due to Diameter Mismatch
Stryker is recalling T2 Tibia Nail Insertion Sleeves because some units have a different inner diameter than labeled.
What this means for you
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 dimensional discrepancy (inner diameter) rather than a direct biological or chemical contamination. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 484 units of the Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile. The affected products include Catalog #1806-1406S (SPI 08-11) and Catalog #1806-1407S (SPI 08-13). These sleeves are intended to ease nail insertion and protect condyle surfaces during tibial fracture fixation.
The recall was initiated after Stryker Orthopaedics received a report indicating that some of the Nail Insertion Sleeves had a different inner diameter than described on the package label. The specific lot numbers and expiration dates for the affected units are listed in the structured product information.
The products were distributed nationwide in the states of California, Florida, Indiana, Maryland, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, and Wisconsin. Healthcare providers and facilities should stop using the affected sleeves and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of t
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 484
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 (9)
- Catalog #1806-1406S - Lot #'s K019A3C
- K031467
- K032811
- K032812
- K06AAA8
- K07F95F and K083672
- expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468
- K03E8AD and K074529
- expiry date 3/31/2019
Distribution
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