Orthopedic Alliance LLC: Medical Device Recall in 2013 - (Recall #: Z-1386-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long

Product Classification:

Class II

Date Initiated: February 20, 2013

Date Posted: June 5, 2013

Recall Number: Z-1386-2013

Event ID: 64588

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.

Status: Terminated

Product Quantity: 26 units

Code Information:

Part No. 194.01.28 194.02.28 194.03.28 195.01.32 195.02.32 195.03.32 188.01.28 188.02.28 188.03.28 188.04.28 188.05.28 189.01.32 189.02.32 189.03.32

Distribution Pattern:

Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated