Limacorporate SMR Glenosphere Impactor/Extractor Recalled for Intra-operative Breakage
Limacorporate is recalling 314 SMR glenosphere impactor/extractor units due to reports of breakage during surgery. The devices were distributed in the US and Australia.
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 medical device with a risk of harm (breakage during surgery) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Limacorporate S.p.A. is recalling 314 units of the SMR glenosphere impactor/extractor. This medical device is used to implant the glenosphere in the SMR Reverse Shoulder replacement. The recall is being conducted due to complaints of intra-operative breakage of the impactors/extractors.
The affected units were distributed nationwide in the United States and in Australia. The specific lot numbers involved in this recall are 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, and 15AA600.
Healthcare providers and patients should contact Limacorporate S.p.A. for further information regarding the recall and potential replacement or repair options.
The recalled product
- Product
- SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
- Manufacturer
- Limacorporate S.p.A
- Hazard
- Affected units
- 314
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 (9)
- Lot numbers: 1390763
- 14AA094
- 14AA431
- 14AA528
- 15AA094
- 15AA557
- 15AA558
- 15AA559
- 15AA600
Distribution
Distributed nationwide across the United States.
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