Zimmer Biomet Recalls PPS RingLoc+ Acetabular Shells Due to Missing Etching
Zimmer Biomet is recalling 15 units of PPS RingLoc+ Acetabular Shells because the product was distributed with missing etching.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation/packaging issue (missing etching) with no reported injuries or illnesses, fitting the Low severity criteria for cosmetic or documentation defects.
Plain-English summary
Zimmer Biomet, Inc. is recalling 15 units of the PPS RingLoc+ Acetabular Shell, Model No. 11-116062, Lot No. 374670. The recall is due to the device being distributed with the etching missing from the product.
The affected devices were distributed domestically to Michigan, Minnesota, and North Dakota. The PPS RingLoc+ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma, or revision of previous arthroplasty, and is intended for uncemented use only.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- 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¿+…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 11-116062
- Lot No. 374670
- UDI No. (01) 0 0880304 59316 9 (17) 270513 (10) 374670
Distribution
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