Recall Z-1603-2014 ยท DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Zimmer, Inc.
DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.
| Date | May 10, 2014 (initiated Mar 19, 2014) |
| Status | Terminated |
| Reason | During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex. |
| Root cause | Labeling mix-ups |
| Action | Zimmer sent an Urgent: Device Removal Letters dated April 8, 2014 to their customers. The letter identified the affected product, probllem and actions to be taken. Customers were instructed to review this notification, iIdentify and quarantine the affected product to prevent further distribution or use, complete the attached Response Form and return it via email. orporateQuality_PostMarket@zimmer.com. Return affected product to: Zimmer Surgical Attn: QA/RA Dept.- Recall 200 West Ohio Avenue Dover, Ohio 44622 USA Please include a copy of the Response Form with the shipment. For returns o |
| Quantity | 131 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.