Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY
Medical device recall Z-1323-2023. Published in FDA’s Enforcement Report on Apr 12, 2023.
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 Apr 12, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 186889 units 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?
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101; g) DBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT; h) DBM T43102 1CC GRAFTON PUTTY, REF T43102; i) DBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT; j) DBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN; k) DBM T43103 2.5CC GRAFTON PUTTY, REF T43103; l) DBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT; m) DBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN; n) DBM T43105 5CC GRAFTON PUTTY, REF T43105; o) DBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT; p) DBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN; q) DBM T43110 10CC GRAFTON PUTTY, REF T43110; r) DBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT; Demineralized Bone Matrix (DBM) product
186889 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers: A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers:…
Every code shown here, 1,995 characters
a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers: A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers: A39801, A40711, A42973, A43546, A44572, A44970, A45136, A45543, A46181, A46352, A46538, A46924, A47103, A47710, A48122, A48391, A50563, A50858, A51802, A52414, A53427, A54070, A54689, A54892; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103, GTIN 00613994960887, Serial Numbers: A39091, A40452, A41163, A41376, A42289, A43008, A43345, A43555, A45523, A45714, A45746, A46289, A47357, A48134, A48230, A50024, A50343, A51014, A53131, A53706, A54060; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105, GTIN 00613994961136, Serial Numbers: A39669, A41187, A41545, A42539, A42923, A43450, A43481, A43500, A43516, A43853, A43932, A43934, A44475, A44665, A44733, A44805, A44986, A45039, A45175, A45282, A45457, A45552, A45556, A45919, A47043, A47390, A47714, A47833, A47885, A48125, A48540, A48816, A49460, A49472, A50596, A51281, A53513, A53897, A54184, A54492, A54615, A54771, A54892, A54982; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110, GTIN 00613994961129, Serial Numbers: A41514, A41616, A42444, A43082, A43201, A43235, A43608, A43805, A43852, A43925, A43955, A44054, A44267, A45150, A45454, A45474, A45680, A46359, A46622, A47260, A47287, A47525, A48070, A48080, A48092, A48565, A49050, A49411, A49520, A49924, A52108, A52214, A52379, A53417, A53518, A54052, A54164, A54172, A54245, A54678, A54994; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101, GTIN 00643169123106, Serial Numbers: A38151-037, A38151-038, A38151-039, A38151-040, A38151-041, A38151-042, A38151-043, A38151-045, A38151-049, A38151-050, A38151-051, A38151-052, A38151-053, A38151-054, A38151-055, A38151-056, A38151-057, A38151-058, A38151-059, A38151-060, A38151-061, A38151-062, A38151-063, A38151-064, A38151-065, A38151-066, A38151-067, A38151-068, A38151-069, A38151-070, A38151-071, A38151-072,…
FDA’s list runs to 2,205,800 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 the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Feb 8, 2023.
- FDA classified it on Apr 4, 2023.
- FDA’s Enforcement Report published it on Apr 12, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Sofamor Danek USA Inc, of Memphis, TN.
- 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 2,205,800 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.