Drug & Device Safety Atlas
Class II FDA device recall · Z-1323-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information 
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, 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Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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.

Recall record

Recalling firm
Medtronic Sofamor Danek USA Inc
Product type
Devices
Recall number
Z-1323-2023
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Memphis, TN
Recall initiated
2023-02-08

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1323-2023 · Source: openFDA enforcement.