Stelkast Cross-over Acetabular Shell and Liner Hip System Recalled
Stelkast Co is recalling 254 units of the Cross-over Acetabular Shell and Liner Hip System due to difficulty engaging and securing the liner.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall, and the rubric specifies that FDA Class II recalls with potential for significant injury or structural defects are rated as Severe (4).
Plain-English summary
Stelkast Co is recalling 254 units of the Stelkast Cross-over Acetabular Shell and Liner Hip System. The affected part numbers are SC3458-52, SC3474-52, SC3459-52, and SC3460-52. These devices are intended for use in the reconstruction of the articulating surface of the acetabular portion of the hip.
The recall was initiated because the firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell. The agency has classified this recall as Class II.
The affected products were distributed nationwide, including the states of Nevada, Oklahoma, and Pennsylvania. Specific lot numbers include 28820-112612, 28822-101812, 28823-101812, and 28821-000. Healthcare providers and patients should contact Stelkast Co for further instructions regarding the recall.
The recalled product
- Product
- Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
- Manufacturer
- Stelkast Co
- Affected units
- 254
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 (8)
- Part Numbers SC3458-52
- lot number 28820-112612
- SC3474-52
- lot number 28822-101812
- SC3459-52
- lot number 28823-101812
- and SC3460-52
- lot number 28821-000.
Distribution
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