Z-1384-2013Class II

Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr...

Name: Z-1384-2013 Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr...
Creator: Orthopedic Alliance LLC
Published: 2013-02-20
License: https://open.fda.gov/license/

Orthopedic Alliance, LLC / initiated 2013-02-20 / Terminated / root cause: labeling and UDI

FDA source

Orthopedic Alliance LLC began a recall of Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone... on 2013-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1384-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-20
Posted: 2013-05-24
Terminated: 2014-03-26
Recalling firm: Orthopedic Alliance, LLC
Product: Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Quantity in commerce: 5 units
Distribution: Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Product codes and lots: Item No. 5201-6715 5201-6720 5201-6725 5201-6730 5201-6735 5201-6740

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1384-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1378-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1379-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1380-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1381-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1382-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1383-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1384-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1385-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1386-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24

Product code HWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)