Recall Z-2173-2011 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Inc.
NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF 00-5901-026-00, Zimmer UK, Ltd., Zimmer Warsaw, IN. Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
| Date | May 10, 2011 (initiated Mar 14, 2011) |
| Status | Terminated |
| Reason | The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo. |
| Root cause | Device Design |
| Action | The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" notice dated March 14, 2011 to its Consignees/customers. The letter described the product, problem, and the actions to be taken. The customers were instructed to stop using the device and quarantine immediately; carry out a physical count of all affected product in their territory and record this data on the Inventory Return Certification Form and fax to (574) 372-4265; ensure they have provided acknowledgement via "email return receipt" upon receiving notification; return the recalled product along with the completed Inventory Return |
| Quantity | 802 devices |
| Distribution | Worldwide distribution: USA (nationwide)including states of: HI, CA, NY, MI, IN, GA, FL, WI, MN, NJ, IL, VA, TX, NC, PA, MS, WA, OR, OH, KS, TN, NH, AZ, NV, UT and AK and countries of : Australia, Canada, China, Germany, India, Japan, Singapore and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031061 | NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS Zimmer, Inc., Oct 9, 2003 |