Stryker Orthopaedics Ball Impactor Tip Recalled for Cracks and Fractures
Stryker Howmedica Osteonics Corp. is recalling Ball Impactor Tips used in surgery due to complaints of cracks and fractures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical instrument fracture) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 1,024 units of Stryker Orthopaedics Ball Impactor Tips. These instruments are used for ADM Surgery and were distributed nationwide in the United States. The recall includes catalog number 1235-0-014 across all lot codes.
The recall was initiated after Stryker received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments. The agency has classified this as a Class II recall.
Healthcare providers and consumers should stop using the affected Ball Impactor Tips immediately. Stryker is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 1,024
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 (1)
- Catalog number 1235-0-014 all lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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