FDA Device

PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended for uncemented use only.

Hazard

Device was distributed with the etching missing from the product.

What You Should Do

Remedy

The firm, Zimmer Biomet, sent an, "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated 6/28/2017 via email and FedEx on approximately 06/29/2017 to its consignees. The letter described the product, problem and actions to be taken. The consignees were Instructed to ensure appropriate personnel are notified, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to:corporatequality.postmarket@zimmerbiomet.com or fax to: 574-372-4265, return all affected products, and provide the names of any locations where product was further distributed to. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com.

Products

PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revisi
Brand
Zimmer Biomet, Inc.
UPC
Model No. 11-116062, Lot No. 374670, UDI No. (01) 0 0880304 59316 9 (17) 270513 (10) 374670

Units Affected

15 units