Synthes Oracle Spacer System Slap Hammer Recalled for Breakage During Use
Synthes USA HQ, Inc. is recalling 27 units of the Oracle Spacer System Slap Hammer because the proximal end broke 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 surgical instrument that broke during use, posing a risk of harm to patients, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes USA HQ, Inc. is recalling 27 units of the Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847. The Slap Hammer is a dual-sided surgical instrument used by surgeons to remove previously placed trial implants during spinal procedures.
The recall was initiated in response to complaints reporting that the proximal end of the Slap Hammer broke during use. The affected units were distributed worldwide, including in the United States (Colorado, Pennsylvania, Tennessee, Virginia, Washington) and internationally to the Czech Republic.
The Oracle Spacer System is indicated for use in patients with degenerative disc disease or for vertebral body replacement in the thoracolumbar spine. Consumers and healthcare providers should stop using the affected Slap Hammer units and contact Synthes USA HQ, Inc. for further instructions.
The recalled product
- Product
- Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combi
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 27
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 (2)
- Part number 03.809.690
- Lot Number 6723847
Distribution
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