Stryker Recalls Hoffman LRF Wire Bolts Due to Breakage During Use
Stryker Howmedica Osteonics is recalling 476 Hoffman LRF Wire Bolts because two complaints reported the wires broke during load-bearing application by patients.
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 reported breakage during load-bearing application, representing a risk of harm where specific injury details are not provided, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 476 units of Hoffman LRF Wire Bolts, catalog numbers 4933-1-001 through -003. The recall is due to two complaints filed where the wires broke during load-bearing application by patients.
The affected products were distributed nationwide, including in Pennsylvania, Ohio, New York, California, and Illinois. Specific lot numbers are associated with each catalog number: 4933-1-001 (lots Z02804, Z08348, Z08350, Z12549, Z16753), 4933-1-002 (lots Z08351, Z12554, Z16246, Z16752), and 4933-1-003 (lots Z08349, Z09344, Z12551, Z16996).
The source text does not provide specific instructions for consumers or patients on how to proceed with the recall or return the devices.
The recalled product
- Product
- Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 476
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 (13)
- Catalog number 4933-1-001
- Lot number Z02804
- Z08348
- Z08350
- Z12549
- Z16753. Catalog number 4933-1-002
- Lot number Z08351
- Z12554
- Z16246
- Z16752. Catalog number 4933-1-003 Lot Number Z08349
- Z09344
- Z12551
- Z16996.
Distribution
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