Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 26, 2020
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.
Multiple lots being recalled due to a product design issue
Smith & Nephew Orthopaedics Ag recalled POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Prod… - a moderate-severity action.
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Prod… was recalled by Smith & Nephew Orthopaedics Ag in August 26, 2020. Reason: Multiple lots being recalled due to a product design issue. Check the official notice for the remedy. Verify recall #Z-2827-2020 with the FDA Devices before acting.
The recall
Smith & Nephew Orthopaedics Ag issued this moderate-severity FDA Devices recall-Multiple lots being recalled due to a product design issue.
- Moderate
- severity level
- 528 units
- affected scope
- Class II
- classification
- August 26, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2827-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2827-2020) was formally reported on August 26, 2020, with the manufacturer initiating the action on July 22, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Smith & Nephew Orthopaedics Ag is listed as the recalling firm, operating out of Aarau, N/A. Federal records list the affected scope as 528 unit.
The documented reason for this recall is: Multiple lots being recalled due to a product design issue Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution including in the state of TN and the countries of AU, BE, CA, CH, ES, FR, GB, JP, NL, NO, PL, SG, ZA.. 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
528 unit
Related Recalls
6
3 from same agency
Product description
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.
Reason for recall
Multiple lots being recalled due to a product design issue
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2827-2020 |
| Date reported | August 26, 2020 |
| Date initiated | July 22, 2020 |
| Recalling firm | Smith & Nephew Orthopaedics Ag |
| Firm location | Aarau, N/A |
| Affected scope | 528 unit |
| Distribution | Worldwide distribution - US Nationwide distribution including in the state of TN and the countries of AU, BE, CA, CH, ES, FR, GB, JP, NL, NO, PL, SG, ZA. |
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-2827-2020) 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? ▼
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.. Recalled by Smith & Nephew Orthopaedics Ag. Units affected: 528 unit.
Why was this product recalled? ▼
Multiple lots being recalled due to a product design issue
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2020. Severity: Moderate. Recall number: Z-2827-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution including in the state of TN and the countries of AU, BE, CA, CH, ES, FR, GB, JP, NL, NO, PL, SG, ZA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2827-2020) 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 August 26, 2020. 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.