Recall Z-0463-2014
Zimmer, Inc. · initiated November 19, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
Codes / lots: Part Number 00-5971-041-09
Reason for recall
This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall.
FDA-determined cause: Labeling design
Action taken
Zimmer sent an Urgent Medical Device Recall Notice dated November 19, 2013, to all affected customers. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product will be removed by a Zimmer Sales representative, Question should be directed to 1-877-946-2761 8a.m - 5 p.m. EST. For questions regarding this recall call 800-613-6131.
Details
- Recall number
- Z-0463-2014
- Initiated
- November 19, 2013
- Posted by FDA
- December 6, 2013
- Terminated
- May 6, 2015
- Product code
- HWT – Template
- Quantity
- 439 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.
- Recalling firm
- Zimmer, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0459-2014 Class II | NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non…This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments… | 11/19/2013Terminated |
| Z-0460-2014 Class II | NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non…This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments… | 11/19/2013Terminated |
| Z-0461-2014 Class II | NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height…This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments… | 11/19/2013Terminated |
| Z-0462-2014 Class II | NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height…This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments… | 11/19/2013Terminated |