CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ…
Medical device recall Z-1058-2018. Published in FDA’s Enforcement Report on Mar 21, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 21, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 13,227 in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ E-R MINUS¿¿ CR-FLEX GSF PCT SZ F-L MINUS¿ CR-FLEX GSF PCT SZ F-R MINUS¿ CR-FLEX GSF PCT SZ G-L MINUS¿ CR-FLEX GSF PCT SZ G-R MINUS¿ “ These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. “ These devices are indicated for cemented use only. “ The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
13,227 in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00-5750-013-01 00-5750-013-02 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750-015-01 00-5750-015-02 00-5750-015-05 00-5750-015-06 00-5750-016-01 00-5750-016-02 00-5750-016-05 00-5750-016-06 00-5750-017-01…
Every code shown here, 1,998 characters
00-5750-013-01 00-5750-013-02 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750-015-01 00-5750-015-02 00-5750-015-05 00-5750-015-06 00-5750-016-01 00-5750-016-02 00-5750-016-05 00-5750-016-06 00-5750-017-01 00-5750-017-02 00-5750-013-01 61951107 00-5750-013-01 61990633 00-5750-013-01 62003770 00-5750-013-01 62088332 00-5750-013-01 62168463 00-5750-013-02 61970680 00-5750-013-02 62004806 00-5750-013-02 62093265 00-5750-013-02 62166656 00-5750-013-06 62120693 00-5750-014-01 61827938 00-5750-014-01 11400140 00-5750-014-01 61844939 00-5750-014-01 61879304 00-5750-014-01 11400196 00-5750-014-01 61905173 00-5750-014-01 61929402 00-5750-014-01 61951674 00-5750-014-01 61964632 00-5750-014-01 61972167 00-5750-014-01 62004808 00-5750-014-01 62029480 00-5750-014-01 62072208 00-5750-014-01 62087759 00-5750-014-01 62093268 00-5750-014-01 62121194 00-5750-014-01 62134274 00-5750-014-01 62159864 00-5750-014-01 62170341 00-5750-014-01 62170342 00-5750-014-01 62170343 00-5750-014-05 62121555 00-5750-014-05 62166655 00-5750-014-02 61791935 00-5750-014-02 61791936 00-5750-014-02 61813666 00-5750-014-02 11400111 00-5750-014-02 61843131 00-5750-014-02 61862167 00-5750-014-02 61870724 00-5750-014-02 61890017 00-5750-014-02 61905264 00-5750-014-02 61914484 00-5750-014-02 61951689 00-5750-014-02 61970681 00-5750-014-02 61978269 00-5750-014-02 61990915 00-5750-014-02 62011560 00-5750-014-02 62022989 00-5750-014-02 62059374 00-5750-014-02 62072514 00-5750-014-02 62088280 00-5750-014-02 62093271 00-5750-014-02 62132082 00-5750-014-02 62134707 00-5750-014-02 62159269 00-5750-014-02 62170344 00-5750-014-02 62170384 00-5750-014-02 62171084 00-5750-014-06 62121229 00-5750-014-06 62135959 00-5750-014-06 62170385 00-5750-015-01 61797750 00-5750-015-01 61804265 00-5750-015-01 61809715 00-5750-015-01 61810409 00-5750-015-01 61819936 00-5750-015-01 61820642 00-5750-015-01 61829061 00-5750-015-01 61834876 00-5750-015-01 61842352 00-5750-015-01 61847666 00-5750-015-01…
FDA’s list runs to 8,702 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 29, 2017.
- FDA classified it on Mar 14, 2018.
- FDA’s Enforcement Report published it on Mar 21, 2018.
- FDA terminated it on Apr 2, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Biomet, Inc., of Warsaw, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 8,702 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.