Z-0043-2018Class II

MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R

Name: Z-0043-2018 MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R
Creator: MicroPort Orthopedics Inc.
Published: 2017-09-18
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2017-09-18 / Terminated / root cause: packaging

FDA source

MicroPort Orthopedics Inc. began a recall of MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip... on 2017-09-18. FDA classified it as Class II and gives the reason as "The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0043-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-18
Posted: 2018-10-11
Terminated: 2021-04-08
Recalling firm: Microport Orthopedics Inc.
Product: MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed
Product code: HWC Screw, Fixation, Bone
Reason for recall: The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Microport initiated their recall by letter sent via email on 09/18/2017. The letter identified the affected product, problem and actions to be taken. The consignees were directed to check their stock, including all kits and consignment stock to immediately determine if any affected product was in stock. The firm requested return of the recalled units. Consignees with questions regarding the return of the product were directed MPOs Customer Experience Department available Monday through Friday 7:30 am to 7:30 pm CST, at 1-866-872-0211.
Quantity in commerce: 48 units
Distribution: Worldwide Distribution - US Nationwide in the states of TX, AL, AZ CO, KS ,ME MO, WB, LA, CA, MD, including PR and the country of CANADA
Product codes and lots: lot 1723305

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0043-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0043-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-01	2017-10-20

Product code HWC

K952296Class IISynthes (USA) [Synthes[ Self-Drilling Schanz ScrewSynthes (Usa) / cleared 1995-08-18

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)