CLASS II Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
Aesculap S4 Cervical Cross Connector L22mm recalled
Aesculap Implant Systems is recalling Aesculap S4 Cervical Cross Connector L22mm, S4C Cross Connector Fixed, product, distributed nationwide in the US. The recall was initiated on 8 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1443-2022
- FDA event ID
- 90502
- Recalling firm
- Aesculap Implant Systems, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Sep 2020
- FDA classified
- 21 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Spinal Implants
Timeline
| 8 Sep 2020 | Recall initiated by company | |
| 21 Jul 2022 | Classified by FDA | +681 days |
| 27 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
Where it was distributed
United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
Nationwide CaliforniaColoradoIllinoisIndianaMichiganNorth CarolinaNevadaOhioPennsylvaniaSouth CarolinaTexasWyoming
Questions about this recall
Is Aesculap S4 Cervical Cross Connector L22mm, S4C Cross Connector Fixed, product recalled?
Yes. Aesculap Implant Systems recalled Aesculap S4 Cervical Cross Connector L22mm, S4C Cross Connector Fixed, product on 8 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-1443-2022.
Why was it recalled?
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Which lots are affected?
UDI-DI: 04038653362295
Where was it sold?
United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aesculap Implant Systems
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | For intraventricular recalled by Aesculap Implant Systems | Aesculap Implant Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Aesculap Surgical Needle, straight, 3 1/2", width recalled | Aesculap Implant Systems | Sterility | Nationwide |
| Device | CLASS II | Aesculap Caiman Articulating D5 recalled by Aesculap Implant Systems | Aesculap Implant Systems | Other | Nationwide |
| Device | CLASS II | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only recalled | Aesculap Implant Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Aesculap Ennovate Set Screw Sterile-implants are used recalled | Aesculap Implant Systems | Sterility | GA, TX |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |