FDA Device recall Z-2197-2017
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training
- FDA Device
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training by Acumed, citing the firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complai….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2197-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-20 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Acumed |
| Distribution | US |
Product
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.
Reason
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
Identifiers
| code_info | Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments. Below are Part numbers/ Descr…Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments. Below are Part numbers/ Description per set: 5001-0106N-S ARH Slide-Loc Standard Stem 6mm 5001-0107N-S ARH Slide-Loc Standard Stem 7mm 5001-0108N-S ARH Slide-Loc Standard Stem 8mm 5001-0109N-S ARH Slide-Loc Standard Stem 9mm 5001-0110N-S ARH Slide-Loc Standard Stem 10mm 5001-0111N-S ARH Slide-Loc Standard Stem 11mm 5001-0112N-S ARH Slide-Loc Standard Stem 12mm 5001-0218L-S ARH Slide-Loc Head 18mm, Left 5001-0218R-S ARH Slide-Loc Head 18mm, Right 5001-0220L-S ARH Slide-Loc Head 20mm, Left 5001-0220R-S ARH Slide-Loc Head 20mm, Right 5001-0222L-S ARH Slide-Loc Head 22mm, Left 5001-0222R-S ARH Slide-Loc Head 22mm, Right 5001-0224L-S ARH Slide-Loc Head 24mm, Left 5001-0224R-S ARH Slide-Loc Head 24mm, Right 5001-0226L-S ARH Slide-Loc Head 26mm, Left 5001-0226R-S ARH Slide-Loc Head 26mm, Right 5001-0228L-S ARH Slide-Loc Head 28mm, Left 5001-0228R-S ARH Slide-Loc Head 28mm, Right 500 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2197-2017%22
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