FDA Device recall Z-2089-2012
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp
- FDA Device
- Class II
- ongoing
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp by Stryker Howmedica Osteonics, citing stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2089-2012 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2012-04-30 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
Reason
Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an
Identifiers
| code_info | 510 K092406 all lots (4845-4XXX and NLS/NLV) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2089-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.