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.
FDA Recall Z-0312-2018 · Posted None
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Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2017-06-29
Date Terminated2018-03-07
Product Quantity15 units
Reason for Recall
Device was distributed with the etching missing from the product.
Firm Action
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:[email protected] 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 [email protected].
Root Cause
Employee error
Distribution Pattern
Distributed domestically to MI, MN, ND.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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