Z-0943-2017Class II

PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN...

Name: Z-0943-2017 PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN...
Creator: MicroPort Orthopedics Inc.
Published: 2016-11-17
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2016-11-17 / Terminated / root cause: manufacturing process

FDA source

MicroPort Orthopedics Inc. began a recall of PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach... on 2016-11-17. FDA classified it as Class II and gives the reason as "The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0943-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-17
Posted: 2017-01-03
Terminated: 2018-08-18
Recalling firm: Microport Orthopedics Inc.
Product: PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: MicroPort Orthopedics sent an Voluntary Device Product Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed form even if they do not have any affected product to return. Return the completed form by fax to 1-901-451-6032 or by email to [email protected]. Attempt #1 for acknowledgment will be made by email. For questions regarding this recall call 901-867-4318.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution to Spain, China, and Italy
Product codes and lots: Lot Number US100122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0943-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0943-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-03

Product code LZO

K012091Class IIPro-FemurWrightmedicaltechnologyinc / cleared 2001-10-03

MDM coverage of this record lists here, newest first.

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)