Summary
The FDA issued a Class II for 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier by Zimmer Surgical Inc. Reason: Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage o.
Details
Source
Device Recall
External ID
Z-1078-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
Product Description
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Lot/Code Info: UDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027)
Quantity Affected: 76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS
Reason for Recall
Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.
Distribution
Worldwide - US Nationwide distribution including in the states of CA, DE, FL, GA, IA, IL, IN, KS, LA, MI, MO, MT, NC, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV and the countries of AUTRALIA, CANADA, DNIPRO OBLAS, HONG KONG, INDIA, JAPAN, MEXICO, CDMX, NETHERLANDS, SEOUL KOREA, SINGAPORE, TAIWAN, THAILAND.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-02
Company
Dover, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zimmer Surgical Inc has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer Surgical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer Surgical Inc have FDA actions?
Zimmer Surgical Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1078-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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