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U.S. Department of Health and Human Services

Class 2 Device Recall PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW

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 Class 2 Device Recall PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREWsee related information
Date Initiated by FirmMay 19, 2025
Date PostedJune 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2025-2025
Recall Event ID 96911
510(K)NumberK212800 
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
ProductPRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Code Information Lot number 2421400/UDI: 08033390201834
FEI Number 3008021110
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
Di San Daniele
San Daniele Del Friuli Italy
For Additional Information ContactLimacorporate Customer Service.
+390432945511
Manufacturer Reason
for Recall		There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
FDA Determined
Cause 2		Process design
ActionOn May 19, 2025, Enovis (Limacorporate S.p.A) issued a recall notification via e-mail. Enovis provided customers with an updated notification on May 28, 2025 to provide additional information. Enovis asked consignees to take the following steps: 1. Review your stock for the products and lot numbers for the items to be returned and quarantine immediately the affected devices. 2. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3. If you have further distributed the product, please provide this recall notification to those consignees; have them complete the acknowledgement form; and notify anyone that they have further distributed the affected product to. 3. Complete the attached acknowledgement form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. You will be provided with an RMA number and shipping label to return the affected product. 4. Return all devices using the RMA number and shipping label provided by Customer Service. Devices must be sent back to: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA within 15 days together with a signed hard copy of the following acknowledgement form.
Quantity in Commerce9 units
DistributionWorldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PHX
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