Stryker Orthopaedics Recalls Rim Impactor Tips Due to Cracks and Fractures
Stryker Howmedica Osteonics Corp. is recalling 1,690 Rim Impactor Tips used in MDM surgery due to complaints of cracks and fractures.
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 3/5 (High).
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 involves a medical device with structural defects (cracks/fractures) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 1,690 units of Stryker Orthopaedics Rim Impactor Tips. These instruments are used for MDM surgery and are identified by catalog number 12350-013 across all lot codes. The products were distributed nationwide in the United States.
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 source text does not report any specific injuries, illnesses, or deaths associated with these defects.
Healthcare providers and consumers should stop using the affected Rim Impactor Tips immediately. Stryker is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 1,690
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 12350-013 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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