Aesculap S4 Cervical Revision Instruments Recalled for Tolerance Issues
Aesculap Implant Systems LLC is voluntarily removing S4 Cervical Revision Instruments because they may not thread into screws properly during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 functional defect that could compromise surgical outcomes, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aesculap Implant Systems LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument, which is part of the S4C Occipital Instrument Set. The specific models involved are the FW099R and FW101R. These instruments are designed to assist in the removal of an occipital cervical screw during revision surgery.
The recall was initiated because the instruments may not thread into the screw properly during a revision surgery. This issue is attributed to tolerance issues between the two instruments. The recall covers 15 units that were distributed nationwide, including the states of California, Colorado, Illinois, Louisiana, Nevada, Ohio, and Texas.
Healthcare providers and facilities that have received these instruments should stop using them immediately. Aesculap Implant Systems LLC is the recalling firm responsible for the removal of these devices from the market.
The recalled product
- Product
- S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 15
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 (1)
- All distributed lot numbers and serial numbers
Distribution
Related recalls
Same manufacturer · Aesculap Implant Systems LLC
See all →- HighTrocar with oversized shaft obscures surgical view in brain operations
FDA (Devices) · 2023-09-13
- ModerateAesculap Surgical Needle Recalled for Incorrect Product Code Marking
FDA (Devices) · 2023-07-26
- HighAesculap Caiman Articulating Surgical Device Recalled for Loose Spring
FDA (Devices) · 2023-05-17
- ModerateCaspar Cervical Retractor Basket Lids Recalled for Incorrect GTIN Labeling
FDA (Devices) · 2023-05-03
- HighAesculap ENNOVATE Spine Implants Recalled for Incorrect Screw Inclusion
FDA (Devices) · 2022-09-07
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- SevereAesculap S4C Occiput Torque Wrench Recalled Due to Reassembly Defect
FDA (Devices) · 2015-08-12
- HighAesculap S4 Polyaxial Screws Recalled for Potential Channel Tolerance Defect
FDA (Devices) · 2012-09-19
- HighAesculap S4 Cervical Cross Connector Recalled Due to Clamping Force Defect
FDA (Devices) · 2022-07-27
- HighCervical spinal implant connectors may fail to maintain proper clamping force
FDA (Devices) · 2022-07-27
- HighSpinal fusion cross connector recalled for insufficient clamping force
FDA (Devices) · 2022-07-27
- HighAesculap S4 Cervical Cross Connector Spinal Implant System Recalled for Clamping Failure
FDA (Devices) · 2022-07-27