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Shoulder Brace with Airplane Kit LOGO

Manamed, Inc. · Model OSAK3-PL · UDI-DI 00810113683034

ILI

510(k) clearances

Adverse events

Recalls

334

Facilities

Description

The Shoulder Brace with Airplane Kit provides support for shoulder surgeries in a universal multiple configuration brace. Suitable for all shoulder surgeries as well as conservative care of shoulder injuries. The Shoulder Brace with Airplane Kit is your new go to shoulder brace for all your clinical needs. Sized universal Low-profile design True Airplane or Gunslinger alignment Two step application Multiple abduction angles Extreme external rotation

Recalls

Date	Firm	Reason
2021-04-12	DJ Orthopedics de Mexico S.A. de C.V.	failed rivet at the chafe tab of arm sling.
2021-04-12	DJ Orthopedics de Mexico S.A. de C.V.	failed rivet at the chafe tab of arm sling.
2021-04-12	DJ Orthopedics de Mexico S.A. de C.V.	failed rivet at the chafe tab of arm sling.
2021-04-12	DJ Orthopedics de Mexico S.A. de C.V.	failed rivet at the chafe tab of arm sling.
2016-10-31	Owens & Minor Distribution, Inc.	Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The Product is manufactured in China by Tops Medical Articles Nantong Inc.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.