Exact FDA event identifier

Event 87727

4 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 12, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: DJ Orthopedics de Mexico S.A. de C.V.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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.

Z-1511-2021

Recall number: Z-1511-2021
Initiated: April 12, 2021
Classification: Class II
Status: Terminated
Recalling firm: DJ Orthopedics de Mexico S.A. de C.V.
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

failed rivet at the chafe tab of arm sling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

failed rivet at the chafe tab of arm sling.

Code information

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

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.

device · product 2 of 4

DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

Z-1512-2021

Recall number: Z-1512-2021
Initiated: April 12, 2021
Classification: Class II
Status: Terminated
Recalling firm: DJ Orthopedics de Mexico S.A. de C.V.
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

failed rivet at the chafe tab of arm sling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

failed rivet at the chafe tab of arm sling.

Code information

Lot Numbers:2021-01-05, 2021-01-07, 2021-01-20, 2021-02-05, 2021-03-09, 2021-03-10, 2021-03-13, 2021-03-16, 2021-03-17, 2021-03-18

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.

device · product 3 of 4

DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

Z-1513-2021

Recall number: Z-1513-2021
Initiated: April 12, 2021
Classification: Class II
Status: Terminated
Recalling firm: DJ Orthopedics de Mexico S.A. de C.V.
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

failed rivet at the chafe tab of arm sling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

failed rivet at the chafe tab of arm sling.

Code information

Lot Numbers: 2021-01-05, 2021-01-20

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.

device · product 4 of 4

DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

Z-1514-2021

Recall number: Z-1514-2021
Initiated: April 12, 2021
Classification: Class II
Status: Terminated
Recalling firm: DJ Orthopedics de Mexico S.A. de C.V.
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

failed rivet at the chafe tab of arm sling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

failed rivet at the chafe tab of arm sling.

Code information

Lot Numbers: 2021-01-05, 2021-01-20, 2021-03-10, 2021-03-11, 2021-03-16

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.