Stryker Recalls Exeter Rasp Handle Due to Malfunctioning
Stryker Howmedica Osteonics Corp. is recalling 241 Exeter Rasp Handles because they may malfunction during use.
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 a malfunctioning hazard where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 241 units of the Exeter Rasp Handle, catalog number 0930-9-003. This reusable orthopedic manual surgical instrument is part of the Exeter femoral hip system and is used to guide rasps into a patient's femur during surgery.
The recall was initiated because the handles are malfunctioning. The Exeter Rasp Handle is designed to be assembled with femoral rasps and locked in place by closing a lever, after which it is impacted using a mallet to remove bone and prepare the femur.
The affected units were distributed worldwide and nationwide in the United States. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 241
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 No. 0930-9-003
Distribution
Distributed nationwide across the United States.
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