Zimmer Biomet, Inc. ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
662230
Products Sold
662230
Zimmer Biomet, Inc. is recalling ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement. due to Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Recommended Action
Per FDA guidance
On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026