DJO Surgical
Cobalt G-HV Bone Cement 40GM
1manufacturer
4catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | LOD |
| Device type | Bone Cement |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2017-01-24 |
| Record revised | 2020-06-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 600-15-000 | In distribution | |
| 600-15-100 | In distribution | |
| 600-10-100 | In distribution | |
| 600-10-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Palacos | Heraeus Medical LLC | 17 |
| Kiva | Benvenue Medical, Inc. | 6 |
| Rally | Smith & Nephew, Inc. | 5 |
| Bone Cement | Depuy (Ireland) | 5 |
| PCD SpinePlex | Stryker GmbH | 4 |
| Simplex | Howmedica Osteonics Corp | 4 |
| Gentafix | Teknimed SAS | 3 |
| Versabond | Smith & Nephew, Inc. | 3 |
| Orthoset® | Microport Orthopedics Inc. | 3 |
| Osteopal® | Heraeus Medical LLC | 3 |
| Prostalac | Depuy Orthopaedics, Inc. | 3 |
| Signature -x Cement | Teknimed SAS | 3 |
Showing 12 of 63. All products under Bone Cement
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-06-26 | Class II | Vendor change control | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | 9848 units | |
| 2017-06-26 | Class II | Vendor change control | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | 1815 units | |
| 2017-06-26 | Class II | Vendor change control | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | 840 units | |
| 2017-06-26 | Class II | Vendor change control | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | 7143 units | |
| 2016-07-26 | Class II | Labeling mix-ups | The outer packaging was mislabeled on the box indicating “Cobalt HV with Gentamicin”. The bone cement does not contain antibiotics. | 866 units | 2017-01-13 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P970010 | 2000-08-31 | NORIAN SRS BONE CEMENT | Synthes (Usa) |
| P960001 | 1999-08-26 | DEPUY 3 BONE CEMENT | Depuy Intl., Ltd. |
| N18466 | 1998-10-21 | ORTHOSET BONE CEMENT | Depuy Intl., Ltd. |
| N17004 | 1996-12-18 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | Howmedica Corp. |
| N17003 | 1993-06-08 | SURGICAL SIMPLEX(R) P BONE CEMENT | Howmedica Corp. |
| P810020 | 1992-02-14 | PALACOS R BONE CEMENT | Smith & Nephew Richards, Inc. |
| N17755 | 1990-08-02 | BONECEMENT | Zimmer, Inc. |
| N17113 | 1981-09-16 | OMNIPLASTIC BONE CEMENT | L.D. Caulk Co. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.