Recall Z-2219-2014 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer, Inc.
VI DBL OFFST W/ LRG STPL, LT Nonsterile
| Date | Aug 14, 2014 (initiated Jul 23, 2014) |
| Status | Terminated |
| Reason | The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. |
| Root cause | Device Design |
| Action | On July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall. Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET. |
| Quantity | 412 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.