Device recall: Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide…
Class II FDA enforcement event 73380. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Ossur H / F started this device recall on 24 Feb 2016. The firm address in the FDA record is in Reykjavik. FDA put the recall in Class II. FDA event 73380 has 14 product records. The first FDA enforcement report date is 6 Apr 2016. The record gives the status Terminated, with the termination date 15 Aug 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
Ossur H / F, Reykjavik, N/A, Iceland.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
14 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1285-2016 | Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities. | 7 | Class II | Terminated | 6 Apr 2016 |
| Z-1286-2016 | Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces. | 456 | Class II | Terminated | 6 Apr 2016 |
| Z-1287-2016 | NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization. | 2010 | Class II | Terminated | 6 Apr 2016 |
| Z-1288-2016 | Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization. | 15,825 | Class II | Terminated | 6 Apr 2016 |
| Z-1289-2016 | Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis. | 1030 | Class II | Terminated | 6 Apr 2016 |
| Z-1290-2016 | Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis. | 24 | Class II | Terminated | 6 Apr 2016 |
| Z-1291-2016 | 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. | 7623 | Class II | Terminated | 6 Apr 2016 |
| Z-1292-2016 | Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers. | 34 | Class II | Terminated | 6 Apr 2016 |
| Z-1293-2016 | Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black | 2 | Class II | Terminated | 6 Apr 2016 |
| Z-1294-2016 | Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. | 15 | Class II | Terminated | 6 Apr 2016 |
| Z-1295-2016 | Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. | 9 | Class II | Terminated | 6 Apr 2016 |
| Z-1296-2016 | Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. | 456 | Class II | Terminated | 6 Apr 2016 |
| Z-1297-2016 | Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. | 7 | Class II | Terminated | 6 Apr 2016 |
| Z-1298-2016 | Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper… | 401 | Class II | Terminated | 6 Apr 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 14Median of the firm: 1
- Events of the firm on the register
- 8
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Aug 2024 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 | Device | Class II | 1 |
| 25 Mar 2024 | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component | Device | Class II | 4 |
| 26 Dec 2023 | Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 | Device | Class II | 1 |
| 12 May 2023 | Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 62 | Device | Class II | 1 |
| 14 Mar 2016 | Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or ch | Device | Class II | 6 |
| 4 Mar 2015 | LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustabl | Device | Class II | 1 |
| 26 Feb 2015 | The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Ar | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1285-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 73380. https://recallregister.com/fda/ii/73380/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 73380?
- The event has 14 product records. The first record gives this quantity:
7
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.