Aesculap S4C Occiput Torque Wrench Recalled Due to Reassembly Defect
Aesculap is recalling 10 S4C Occiput Torque Wrenches because improper reassembly after reprocessing caused a screw to break during implantation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a device failure (screw breakage) during implantation, which aligns with the rubric criteria for Severe severity involving significant injury or structural defects.
Plain-English summary
Aesculap, Inc. is recalling 10 units of the S4C Occiput Torque Wrench F/Set Screw (Product Code FW103R, all lots). The device is used to tighten clamping screws in the S4 Cervical Spinal System with a defined torque of 2.8 Nm. The recall covers units distributed nationwide in the United States and to Canada.
The recall was initiated because a torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to excessive torque. The firm did not include instructions for reassembly after reprocessing, which contributed to the defect.
Healthcare providers and facilities should stop using the affected torque wrenches and contact Aesculap, Inc. for further instructions on the recall.
The recalled product
- Product
- S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
- Manufacturer
- Aesculap, Inc.
- Affected units
- 10
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)
- product: FW103R
- all Lots
Distribution
Distributed nationwide across the United States.
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