Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 2, 2016
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellect
LDPE bag containing the implant adheres to the highly polished implant surface.
Zimmer Biomet, Inc. recalled LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol… — a moderate-severity action.
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol… was recalled by Zimmer Biomet, Inc. in March 2, 2016. Reason: LDPE bag containing the implant adheres to the highly polished implant surface.. Check the official notice for the remedy. Verify recall #Z-0830-2016 with the FDA Devices before acting.
The recall
Zimmer Biomet, Inc. issued this moderate-severity FDA Devices recall — LDPE bag containing the implant adheres to the highly polished implant surface..
- Moderate
- severity level
- 84K units
- affected scope
- Class II
- classification
- March 2, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0830-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0830-2016) was formally reported on March 2, 2016, with the manufacturer initiating the action on January 11, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 84396.
The documented reason for this recall is: LDPE bag containing the implant adheres to the highly polished implant surface. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN…. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
84396
Related Recalls
6
6 from same agency
Product description
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only. " The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). " Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees."
Reason for recall
LDPE bag containing the implant adheres to the highly polished implant surface.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0830-2016 |
| Date reported | March 2, 2016 |
| Date initiated | January 11, 2016 |
| Recalling firm | Zimmer Biomet, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 84396 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL … |
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-0830-2016) 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? ▼
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only. " The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). " Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.". Recalled by Zimmer Biomet, Inc.. Units affected: 84396.
Why was this product recalled? ▼
LDPE bag containing the implant adheres to the highly polished implant surface.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0830-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0830-2016) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 2, 2016.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.