Data Foundry

Medical device recalls 2013

Bipolar Cap — Class II medical device recall Z-1383-2013

Terminated recall by Orthopedic Alliance LLC, reported 2013-06-05, distributed nationwide. The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic

Recall numberZ-1383-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmOrthopedic Alliance LLC, Murrieta, CA, United States
Recall initiated2013-02-20
Classified2013-05-24
Reported by FDA2013-06-05
Terminated2014-03-26
DistributedNationwide (US)
Quantity37 units
Model numbers1503-3042, 1503-3144, 1503-3146, 1503-3148, 1503-3150, 1503-3152, 1503-3154, 1503-3156

Product

Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm

Reason for recall

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1383-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.