Recall Z-2086-2014 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Exactech, Inc.
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
| Date | Jul 21, 2014 (initiated Mar 7, 2014) |
| Status | Terminated |
| Reason | The femoral stem is lacking specified plasma coating. |
| Root cause | Component design/selection |
| Action | Exactech sent an Important Product Recall Notice dated March 10, 2014, to all affected customers. The notice identified the product the problem and the action to be taken by the customer. Description of Issue: The femoral stem is lacking specified plasma spray coating. Clinical Impact: Without plasma spray coating, the stem may not remain stable and will not have the possibility for biological fixation. In order to comply with applicable regulations and Exactech policies customers were instructed to : " Immediately cease distribution or use of these products. " Extend this information to y |
| Quantity | 10 |
| Distribution | Worldwide Distribution including Spain, Greece and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042843 | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS Ambu, Inc., Nov 12, 2004 |