Z-1291-2016Class II

Rebound Air Walker

Name: Z-1291-2016 Rebound Air Walker
Creator: Ossur H / F
Published: 2016-02-24
License: https://open.fda.gov/license/

Ossur Iceland ehf. / initiated 2016-02-24 / Terminated / root cause: labeling and UDI

FDA source

Ossur H / F began a recall of 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... on 2016-02-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1291-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-24
Posted: 2016-03-31
Terminated: 2016-08-15
Recalling firm: Ossur Iceland ehf.
Product: 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.
Product code: ITW Joint, Ankle, External Brace
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
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The firm sent out customer notification letters on 02/26/16. The notification letter instructed customers to include the latex caution notice in any existing inventory of affected products. The latex caution notice can be retrieved at the conclusion of the response survey or by going directly to safetyalerts.ossur.com. Should customers require ssur to provide pre-printed notices for existing inventory, contact ssur customer service. For the ssur Miami J Cervical Collars with lot numbers before MX150727 customers are instructed to remove and discard the assist strap, which contains natural rubber latex, located in the patient pack. Recipients of the notice with should take the following actions: 1. Pass the notice to those who need to be aware within the organization or to any organization where the affected devices have been transferred. 2. Maintain awareness on this notification for an appropriate period. 3. If have further distributed the products, identify customers and notify them at once of the product alert. It is recommended to include a copy of the alert notification letter. 4. If any of your customers are currently wearing a product, check for any skin irritations or other reactions consistent with natural rubber latex allergies. 5. To verify have received the notification, visit safetyalerts.ossur.com to complete the Response Survey. If any questions, contact ssur Customer Service at (800) 233-6263. The notification letter for the Papoose Infant Spine Immobilizer contained the following additional actions/instructions: Examine inventory, quarantine products subject to the recall and contact customer service for a return authorization to return the product to ssur. If any of customers are currently wearing a product, it is recommended replacing the unit with one shipped after the transition lot number MX150727. Check for any skin irritations or other reactions consistent with natural rubber latex allergies.
Quantity in commerce: 7623
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1291-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1285-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1286-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1287-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1288-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1289-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1290-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1291-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1292-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1293-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1294-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1295-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1296-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1297-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1298-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

Product code ITW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)