ArthroCare Recalls SmartStitch Connectors Due to Manufacturing Error
ArthroCare Corporation is voluntarily recalling 15,559 units of Smith&Nephew SmartStitch PerfectPasser Connectors because a manufacturing error may cause the upper jaw to detach 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 where the device could detach during use, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
ArthroCare Corporation is voluntarily recalling 15,559 units of the Smith&Nephew SmartStitch PerfectPasser Connector (REF # OM-8010). The recall is being initiated due to a manufacturing error that resulted in incorrect upper jaw dimensions.
The defect poses a risk that the upper jaw could potentially disengage or detach during use. The affected units are distributed across numerous U.S. states and several international locations, including Canada, the United Kingdom, and various European and Asian countries.
Healthcare providers and patients should stop using the affected devices immediately. ArthroCare Corporation is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
- Manufacturer
- ArthroCare Corporation
- Affected units
- 15,559
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 (20)
- Batch Numbers: 1154857
- 1179855
- 1184077
- 1194208
- 2005153
- 1154858
- 1179856
- 1184078
- 1194763
- 2005154
- 1156429
- 1179857
- 1184825
- 2001517
- 2005251
- 1165209
- 1179858
- 1184826
- 2001518
- 2005252
Distribution
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