CLASS II Device recall · Reported 5 May 2021 · FDA Enforcement Report
Donjoy REF:11-0447-9-Ultrasling PRO, Universal, Rx Only recalled
DJ Orthopedics de Mexico is recalling Donjoy REF:11-0447-9-Ultrasling PRO, Universal, Rx Only, distributed nationwide in the US. The recall was initiated on 12 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1511-2021
- FDA event ID
- 87727
- Recalling firm
- DJ Orthopedics de Mexico, Tijuana, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Apr 2021
- FDA classified
- 29 Apr 2021
- Reported
- 5 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Apr 2021 | Recall initiated by company | |
| 29 Apr 2021 | Classified by FDA | +17 days |
| 5 May 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
failed rivet at the chafe tab of arm sling.
Product as listed by the FDA
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
Questions about this recall
Why was it recalled?
failed rivet at the chafe tab of arm sling.
Which lots are affected?
Lot Numbers: 2020-11-17, 2020-11-28, 2020-11-29, 2020-11-30, 2020-12-02, 2020-12-07, 2020-12-09, 2020-12-10, 2020-12-11, 2020-12-12, 2020-12-13, 2021-01-12, 2021-01-13, 2021-01-14, 2021-01-15, 2021-01-20, 2021-02-02, 2021-02-03, 2021-02-04, 2021-02-05, 2021-02-09, 2021-02-11, 2021-02-12, 2021-02-13, 2021-02-14, 2021-02-15, 2021-02-16, 2021-02-21, 2021-02-22, 2021-02-23, 2021-02-24, 2021-02-25, 2021-02-27, 2021-02-28, 2021-03-01, 2021-03-02, 2021-03-03, 2021-03-04, 2021-03-09, 2021-03-10, 2021-03-11, 2021-03-12, 2021-03-13, 2021-03-18, 2021-03-19
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 87727This product is part of a recall event; the main page for the event is Donjoy REF:11-0472-9 Ultrasling PRO ER/IR 30, Universal, Rx Only recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Donjoy REF:11-0472-9 Ultrasling PRO ER/IR 30, Universal, Rx Only recalled | DJ Orthopedics de Mexico | Other | Nationwide | |
| CLASS II | Donjoy REF:11-0473-9 Ultrasling PRO AB, Universal, Rx Only, UDI recalled | DJ Orthopedics de Mexico | Other | Nationwide | |
| CLASS II | Donjoy REF:11-0471-9 Ultrasling PRO ER/IR 15, Universal, Rx Only recalled | DJ Orthopedics de Mexico | Other | Nationwide |
More recalls from DJ Orthopedics de Mexico
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Donjoy REF:11-0471-9 Ultrasling PRO ER/IR 15, Universal, Rx Only recalled | DJ Orthopedics de Mexico | Other | Nationwide |
| Device | CLASS II | Donjoy REF:11-0473-9 Ultrasling PRO AB, Universal, Rx Only, UDI recalled | DJ Orthopedics de Mexico | Other | Nationwide |
| Device | CLASS II | Donjoy REF:11-0472-9 Ultrasling PRO ER/IR 30, Universal, Rx Only recalled | DJ Orthopedics de Mexico | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |