Lima Delta Cup Beater Positioner Recalled for Potential Welding Defects
Lima is recalling 20 Delta Cup Beater Positioner units in the US due to suboptimal welding that may reduce mechanical strength and cause breakage 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 risk-of-harm product (medical device breakage) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Limacorporate S.p.A is recalling 20 units of the Delta Cup Beater Positioner - Aligner, model # 9057.20.555, in the United States. This medical device is used during the implantation of the Delta Acetabular System. The recall involves specific lots identified by codes such as 15AG0HJ, 15AG0HQ, and 15AG0UY.
The recall was initiated after an internal analysis of complaints indicated that the welding process may have been performed sub-optimally in the 12 affected lots. This defect could lead to reduced mechanical strength of the device, resulting in possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
The affected products were distributed worldwide, including in the United States and various international markets. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for further instructions on return or replacement.
The recalled product
- Product
- Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
- Manufacturer
- Limacorporate S.p.A
- Affected units
- 20
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 (12)
- Lot # 15AG0HJ
- 15AG0HQ
- 15AG0UY
- 15AG00P
- 15AG040
- 15AG08Y
- 14AG243
- 15AG00Q
- 15AG0UZ
- 15AG0V0
- 15AG0HN
- 16AG02J
Distribution
Distribution scope not specified by the agency.
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