Home › Device types › JDK
Prosthesis, Hip, Cement Restrictor
FDA product code JDK · Class 2 · General, Plastic Surgery
50
Registered devices
98
Adverse events
12
Recalls
54
510(k) clearances
Devices with this code
ShurFit CRT Peek Cage — PRECISION SPINE, INC.Cement Restrictor — TECRES SPATHREADED CR-Ti — MEDTRONIC SOFAMOR DANEK, INC.Cement Restrictor — TECRES SPAShurFit ACIF Titanium — PRECISION SPINE, INC.N/A — MEDTRONIC SOFAMOR DANEK, INC.ShurFit CRT Peek Cage — PRECISION SPINE, INC.MectaPlug PE II — Medacta International SACD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.ShurFit CRT Peek Cage — PRECISION SPINE, INC.ShurFit CRT Peek Cage — PRECISION SPINE, INC.ShurFit ACIF Titanium — PRECISION SPINE, INC.N/A — MEDTRONIC SOFAMOR DANEK, INC.ShurFit ACIF Titanium — PRECISION SPINE, INC.THREADED CR-Ti — MEDTRONIC SOFAMOR DANEK, INC.MectaPlug PE II — Medacta International SAShurFit CRT Peek Cage — PRECISION SPINE, INC.MectaPlug PE II — Medacta International SACement Restrictor — TECRES SPABIOSTOP — DEPUY ORTHOPAEDICS, INC.MectaCem BonePrep — TECRES SPACemex Prep Kit — TECRES SPACement Restrictor — TECRES SPATHREADED CR-Ti — MEDTRONIC SOFAMOR DANEK, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2011-01-27 | Depuy Orthopaedics, Inc. | The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compr |
| 2011-01-27 | Depuy Orthopaedics, Inc. | The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compr |
| 2011-01-27 | Depuy Orthopaedics, Inc. | The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compr |
| 2011-01-27 | Depuy Orthopaedics, Inc. | The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compr |
| 2011-01-27 | Depuy Orthopaedics, Inc. | The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compr |
| 2007-09-19 | Encore Medical, Lp | Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications. |
| 2007-09-19 | Encore Medical, Lp | Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications. |
| 2007-09-19 | Encore Medical, Lp | Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications. |
| 2007-09-19 | Encore Medical, Lp | Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.