High FDA (Devices)·Z-0068-2018·Announced 2017-11-15

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.

What this means for you

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
Category: Medical Device — Surgical Instrument
Hazard: structural-failure
breakage
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.

Same manufacturer · Limacorporate S.p.A

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