DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright
FDA device recall Z-2212-2010 · posted 2010-08-12 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method.
- Action taken
- On 06/28/2010, Wright Medical Technology sent a letter to consignees. Consignees were instructed to examine their inventory for recalled product and return it to the firm. Consignees should contact customer service at 800-238-7117 for return instructions and replacement inventory. Questions concerning the recall should be directed to Debby Daurer at 800-874-5630.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- JDL
- Quantity affected
- 6 units
- Distribution
- USA distirbution only, in states of WI, WV, IN, IA, and GA
- Date initiated
- 2010-06-07
- Date posted
- 2010-08-12
- Date terminated
- 2011-05-31
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER (K082924) | Wrightmedicaltechnologyinc | 2009-03-06 |