Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 1, 2017
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 rheumat
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
MicroPort Orthopedics Inc. recalled MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Produ… - a moderate-severity action.
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Produ… was recalled by MicroPort Orthopedics Inc. in November 1, 2017. Reason: The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss o…. Check the official notice for the remedy. Verify recall #Z-0043-2018 with the FDA Devices before acting.
The recall
MicroPort Orthopedics Inc. issued this moderate-severity FDA Devices recall-The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss o….
- Moderate
- severity level
- 48 units
- affected scope
- Class II
- classification
- November 1, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0043-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0043-2018) was formally reported on November 1, 2017, with the manufacturer initiating the action on September 18, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. MicroPort Orthopedics Inc. is listed as the recalling firm, operating out of Arlington, TN. Federal records list the affected scope as 48 units.
The documented reason for this recall is: 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 advers… Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
48 units
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0043-2018 |
| Date reported | November 1, 2017 |
| Date initiated | September 18, 2017 |
| Recalling firm | MicroPort Orthopedics Inc. |
| Firm location | Arlington, TN |
| Affected scope | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0043-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by MicroPort Orthopedics Inc.. Units affected: 48 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2017. Severity: Moderate. Recall number: Z-0043-2018.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0043-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 1, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.