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 Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in total hip arthroplasty.
This recall has been terminated (originally issued August 12, 2010).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- June 7, 2010
- Posted
- August 12, 2010
- Terminated
- May 31, 2011
- Recall Number
- Z-2212-2010
- Quantity
- 6 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
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.
Distribution
USA distirbution only, in states of WI, WV, IN, IA, and GA
Lot / Code Info
Lot number: 0501136375
Root Cause
Software design (manufacturing process)
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.