Z-1291-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2016
- Initiation Date
- February 24, 2016
- Termination Date
- August 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7623
Product Description
Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
Reason for Recall
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p
Distribution Pattern
U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
Code Information
Item No: B-242900001 B-242900001E B-242900001SE B-242900002 B-242900002E B-242900002SE B-242900003 B-242900003E B-242900003SE B-242900004 B-242900004E B-242900004SE B-242900005 B-242900005E B-242900005SE B-242900061 B-242900061E B-242900061SE B-242900062 B-242900062E B-242900062SE B-242900063 B-242900063E B-242900063SE B-242900064 B-242900064E B-242900064SE B-242900065 B-242900065E B-242900065SE