Z-2188-2020Class II
Osteovation 5Cc Impactformula. Ref/udi: 390-2105/00813845020085 -
Osteomed / initiated 2020-04-02 / Terminated / root cause: supplier
Osteomed, LLC began a recall of OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the... on . FDA classified it as Class II and gives the reason as "Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.
Recall record
- Recall number
- Z-2188-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Osteomed
- Product
- OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Product code
- MQV Filler, Bone Void, Calcium Compound
- Reason for recall
- Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- Root cause tag
- supplier
- FDA root cause
- Vendor change control
- Action
- On 04/02/2020, an URGENT Medical Device Recall letter was sent to all consignees affected by the recall. OsteoMed has requested that affected customers: (1) review this letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email or fax; and (2) return unused inventory via Federal Express (using OsteMed account)
- Quantity in commerce
- 1724
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA. MA, MD, ME. MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of AUSTRALIA, ITALY, KOREA, MALAYSIA, PERU, SINGAPORE and THAILAND.
- Product codes and lots
- LOT 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043 and 1142210
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2180-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2181-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2182-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2183-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2184-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2185-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2186-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2187-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2188-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2189-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2190-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2191-2020 | Class II | Terminated | Voluntary: Firm initiated |
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